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SUBCHAPTER V - DRUGS AND DEVICES
PART A - DRUGS AND DEVICES
§ 351. Adulterated drugs and devices.
A drug or device shall be deemed to be adulterated -
- (a) Poisonous, insanitary, etc., ingredients; adequate controls in
manufacture
- (1) If it consists in whole or in part of any filthy, putrid, or decomposed
substance; or
- (2)
- (A) if it has been prepared, packed, or held under insanitary conditions
whereby it may have been contaminated with filth, or whereby it may have been
rendered injurious to health; or
- (B) if it is a drug and the methods used in, or the facilities or controls
used for, its manufacture, processing, packing, or holding do not conform to or
are not operated or administered in conformity with current good manufacturing
practice to assure that such drug meets the requirements of this chapter as to
safety and has the identity and strength, and meets the quality and purity
characteristics, which it purports or is represented to possess; or
- (3) if its container is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health; or
- (4) if (A) it bears or contains, for purposes of coloring only, a color
additive which is unsafe within the meaning of section 379e(a) of this title, or
(B) it is a color additive the intended use of which in or on drugs or devices
is for purposes of coloring only and is unsafe within the meaning of section
379e(a) of this title; or
- (5) if it is a new animal drug which is unsafe within the meaning of
section 360b of this title; or
- (6) if it is an animal feed bearing or containing a new animal drug, and
such animal feed is unsafe within the meaning of section 360b of this title.
- (b) Strength, quality, or purity differing from official
compendium
If it purports to be or is represented as a drug the name of which is
recognized in an official compendium, and its strength differs from, or its
quality or purity falls below, the standard set forth in such compendium. Such
determination as to strength, quality, or purity shall be made in accordance
with the tests or methods of assay set forth in such compendium, except that
whenever tests or methods of assay have not been prescribed in such compendium,
or such tests or methods of assay as are prescribed are, in the judgment of the
Secretary, insufficient for the making of such determination, the Secretary
shall bring such fact to the attention of the appropriate body charged with the
revision of such compendium, and if such body fails within a reasonable time to
prescribe tests or methods of assay which, in the judgment of the Secretary, are
sufficient for purposes of this paragraph, then the Secretary shall promulgate
regulations prescribing appropriate tests or methods of assay in accordance with
which such determination as to strength, quality, or purity shall be made. No
drug defined in an official compendium shall be deemed to be adulterated under
this paragraph because it differs from the standard of strength, quality, or
purity therefor set forth in such compendium, if its difference in strength,
quality, or purity from such standard is plainly stated on its label. Whenever a
drug is recognized in both the United States Pharmacopoeia and the Homoeopathic
Pharmacopoeia of the United States it shall be subject to the requirements of
the United States Pharmacopoeia unless it is labeled and offered for sale as a
homoeopathic drug, in which case it shall be subject to the provisions of the
Homoeopathic Pharmacopoeia of the United States and not to those of the United
States Pharmacopoeia.
- (c) Misrepresentation of strength, etc., where drug is
unrecognized in compendium
If it is not subject to the provisions of paragraph (b) of this section and
its strength differs from, or its purity or quality falls below, that which it
purports or is represented to possess.
- (d) Mixture with or substitution of another substance
If it is a drug and any substance has been (1) mixed or packed therewith so
as to reduce its quality or strength or (2) substituted wholly or in part
therefor.
- (e) Devices not in conformity with performance standards
If it is, or purports to be or is represented as, a device which is subject
to a performance standard established under section 360d of this title unless
such device is in all respects in conformity with such standard.
- (f) Certain class III devices
- (1) If it is a class III device -
- (A)
- (i) which is required by a regulation promulgated under subsection (b) of
section 360e of this title to have an approval under such section of an
application for premarket approval and which is not exempt from section 360e of
this title under section 360j(g) of this title, and
- (ii)
- (I) for which an application for premarket approval or a notice of
completion of a product development protocol was not filed with the Secretary
within the ninety-day period beginning on the date of the promulgation of such
regulation, or
- (II) for which such an application was filed and approval of the
application has been denied, suspended, or withdrawn, or such a notice was filed
and has been declared not completed or the approval of the device under the
protocol has been withdrawn;
- (B)
- (i) which was classified under section 360c(f) of this title into class
III, which under section 360e(a) of this title is required to have in effect an
approved application for premarket approval, and which is not exempt from
section 360e of this title under section 360j(g) of this title, and
- (ii) which has an application which has been suspended or is otherwise not
in effect; or
- (C) which was classified under section 360j(l) of this title into class
III, which under such section is required to have in effect an approved
application under section 360e of this title, and which has an application which
has been suspended or is otherwise not in effect.
- (2)
- (A) In the case of a device classified under section 360c(f) of this title
into class III and intended solely for investigational use, paragraph (FOOTNOTE
1) (1)(B) shall not apply with respect to such device during the period ending
on the ninetieth day after the date of the promulgation of the regulations
prescribing the procedures and conditions required by section 360j(g)(2) of this
title. (FOOTNOTE 1) So in original. Probably should be ''subparagraph''.
- (B) In the case of a device subject to a regulation promulgated under
subsection (b) of section 360e of this title, paragraph (FOOTNOTE 1) (1) shall
not apply with respect to such device during the period ending -
- (i) on the last day of the thirtieth calendar month beginning after the
month in which the classification of the device in class III became effective
under section 360c of this title, or
- (ii) on the ninetieth day after the date of the promulgation of such
regulation, whichever occurs later.
If it is a banned device.
- (h) Manufacture, packing, storage, or installation of device not
in conformity with applicable requirements or conditions
If it is a device and the methods used in, or the facilities or controls
used for, its manufacture, packing, storage, or installation are not in
conformity with applicable requirements under section 360j(f)(1) of this title
or an applicable condition prescribed by an order under section 360j(f)(2) of
this title.
- (i) Failure to comply with requirements under which device was
exempted for investigational use
If it is a device for which an exemption has been granted under section
360j(g) of this title for investigational use and the person who was granted
such exemption or any investigator who uses such device under such exemption
fails to comply with a requirement prescribed by or under such section.
§ 352. Misbranded drugs and devices.
A drug or device shall be deemed to be misbranded -
- (a) False or misleading label
If its labeling is false or misleading in any particular.
- (b) Package form; contents of label
If in package form unless it bears a label containing (1) the name and place
of business of the manufacturer, packer, or distributor; and (2) an accurate
statement of the quantity of the contents in terms of weight, measure, or
numerical count: Provided, That under clause (2) of this paragraph reasonable
variations shall be permitted, and exemptions as to small packages shall be
established, by regulations prescribed by the Secretary.
- (c) Prominence of information on label
If any word, statement, or other information required by or under authority
of this chapter to appear on the label or labeling is not prominently placed
thereon with such conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to render it likely
to be read and understood by the ordinary individual under customary conditions
of purchase and use.
- (d) Habit forming substances
If it is for use by man and contains any quantity of the narcotic or
hypnotic substance alpha eucaine, barbituric acid, betaeucaine, bromal,
cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana,
morphine, opium, paraldehyde, peyote, or sulphonmethane; or any chemical
derivative of such substance, which derivative has been by the Secretary, after
investigation, found to be, and by regulations designated as, habit forming;
unless its label bears the name and quantity or proportion of such substance or
derivative and in juxtaposition therewith the statement ''Warning - May be habit
forming.''
- (e) Designation of drugs or devices by established names
- (1) If it is a drug, unless (A) its label bears, to the exclusion of any
other nonproprietary name (except the applicable systematic chemical name or the
chemical formula),
- (i) the established name (as defined in subparagraph (3)) of the drug, if
such there be, and
- (ii), in case it is fabricated from two or more ingredients, the
established name and quantity of each active ingredient, including the quantity,
kind, and proportion of any alcohol, and also including, whether active or not,
the established name and quantity or proportion of any bromides, ether,
chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine,
hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury ouabain
strophanthin, strychnine, thyroid, or any derivative or preparation of any such
substances, contained therein; Provided, That the requirement for stating the
quantity of the active ingredients, other than the quantity of those
specifically named in this paragraph, shall apply only to prescription drugs;
and
- (B) for any prescription drug the established name of such drug or
ingredient, as the case may be, on such label (and on any labeling on which a
name for such drug or ingredient is used) is printed prominently and in type at
least half as large as that used thereon for any proprietary name or designation
for such drug or ingredient: Provided, That to the extent that compliance with
the requirements of clause (A)(ii) or clause (B) of this subparagraph is
impracticable, exemptions shall be established by regulations promulgated by the
Secretary.
- (2) If it is a device and it has an established name, unless its label
bears, to the exclusion of any other nonproprietary name, its established name
(as defined in subparagraph (4)) prominently printed in type at least half as
large as that used thereon for any proprietary name or designation for such
device, except that to the extent compliance with the requirements of this
subparagraph is impracticable, exemptions shall be established by regulations
promulgated by the Secretary.
- (3) As used in subparagraph (1), the term ''established name'', with
respect to a drug or ingredient thereof, means (A) the applicable official name
designated pursuant to section 358 of this title, or (B), if there is no such
name and such drug, or such ingredient, is an article recognized in an official
compendium, then the official title thereof in such compendium, or (C) if
neither clause (A) nor clause (B) of this subparagraph applies, then the common
or usual name, if any, of such drug or of such ingredient, except that where
clause (B) of this subparagraph applies to an article recognized in the United
States Pharmacopeia and in the Homoeopathic Pharmacopoeia under different
official titles, the official title used in the United States Pharmacopeia shall
apply unless it is labeled and offered for sale as a homoeopathic drug, in which
case the official title used in the Homoeopathic Pharmacopoeia shall apply.
- (4) As used in subparagraph (2), the term ''established name'' with respect
to a device means (A) the applicable official name of the device designated
pursuant to section 358 of this title, (B) if there is no such name and such
device is an article recognized in an official compendium, then the official
title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of
this subparagraph applies, then any common or usual name of such device.
- (f) Directions for use and warnings on label
Unless its labeling bears (1) adequate directions for use; and (2) such
adequate warnings against use in those pathological conditions or by children
where its use may be dangerous to health, or against unsafe dosage or methods or
duration of administration or application, in such manner and form, as are
necessary for the protection of users, except that where any requirement of
clause •(1) of this paragraph, as applied to any drug or device, is not
necessary for the protection of the public health, the Secretary shall
promulgate regulations exempting such drug or device from such requirement.
- (g) Representations as recognized drug; packing and labeling;
inconsistent requirements for designation of drug
If it purports to be a drug the name of which is recognized in an official
compendium, unless it is packaged and labeled as prescribed therein. The method
of packing may be modified with the consent of the Secretary. Whenever a drug is
recognized in both the United States Pharmacopoeia and the Homoeopathic
Pharmacopoeia of the United States, it shall be subject to the requirements of
the United States Pharmacopoeia with respect to packaging and labeling unless it
is labeled and offered for sale as a homoeopathic drug, in which case it shall
be subject to the provisions of the Homoeopathic Pharmacopoeia of the United
States, and not those of the United States Pharmacopoeia, except that in the
event of inconsistency between the requirements of this paragraph and those of
paragraph (e) as to the name by which the drug or its ingredients shall be
designated, the requirements of paragraph (e) shall prevail.
- (h) Deteriorative drugs; packing and labeling
If it has been found by the Secretary to be a drug liable to deterioration,
unless it is packaged in such form and manner, and its label bears a statement
of such precautions, as the Secretary shall by regulations require as necessary
for the protection of the public health. No such regulation shall be established
for any drug recognized in an official compendium until the Secretary shall have
informed the appropriate body charged with the revision of such compendium of
the need for such packaging or labeling requirements and such body shall have
failed within a reasonable time to prescribe such requirements.
- (i) Drug; misleading container; imitation; offer for sale under
another name
- (1) If it is a drug and its container is so made, formed, or filled as to
be misleading; or
- (2) if it is an imitation of another drug; or (3) if it is offered for sale
under the name of another drug.
- (j) Health-endangering when used as prescribed
If it is dangerous to health when used in the dosage or manner, or with the
frequency or duration prescribed, recommended, or suggested in the labeling
thereof.
- (k) Insulin not properly certified
If it is, or purports to be, or is represented as a drug composed wholly or
partly of insulin, unless (1) it is from a batch with respect to which a
certificate or release has been issued pursuant to section 356 of this title,
and (2) such certificate or release is in effect with respect to such drug.
- (l) Antibiotic drugs improperly certified
If it is, or purports to be, or is represented as a drug (except a drug for
use in animals other than man) composed wholly or partly of any kind of
penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any
other antibiotic drug, or any derivative thereof, unless (1) it is from a batch
with respect to which a certificate or release has been issued pursuant to
section 357 of this title, and (2) such certificate or release is in effect with
respect to such drug: Provided, That this paragraph shall not apply to any drug
or class of drugs exempted by regulations promulgated under section 357(c) or
(d) of this title.
- (m) Color additives; packing and labeling
If it is a color additive the intended use of which is for the purpose of
coloring only, unless its packaging and labeling are in conformity with such
packaging and labeling requirements applicable to such color additive, as may be
contained in regulations issued under section 379e of this title.
- (n) Prescription drug advertisements: established name;
quantitative formula; side effects, contraindications, and effectiveness; prior
approval; false advertising; labeling; construction of the Convention on
Psychotropic Substances
In the case of any prescription drug distributed or offered for sale in any
State, unless the manufacturer, packer, or distributor thereof includes in all
advertisements and other descriptive printed matter issued or caused to be
issued by the manufacturer, packer, or distributor with respect to that drug a
true statement of
- (1) the established name as defined in paragraph (e) of this section,
printed prominently and in type at least half as large as that used for any
trade or brand name thereof,
- (2) the formula showing quantitatively each ingredient of such drug to the
extent required for labels under paragraph (e) of this section, and
- (3) such other information in brief summary relating to side effects,
contraindications, and effectiveness as shall be required in regulations which
shall be issued by the Secretary in accordance with the procedure specified in
section 371(e) of this title, except that (A) except in extraordinary
circumstances, no regulation issued under this paragraph shall require prior
approval by the Secretary of the content of any advertisement, and (B) no
advertisement of a prescription drug, published after the effective date of
regulations issued under this paragraph applicable to advertisements of
prescription drugs, shall with respect to the matters specified in this
paragraph or covered by such regulations, be subject to the provisions of
sections 52 to 57 of title 15. This paragraph (n) shall not be applicable to any
printed matter which the Secretary determines to be labeling as defined in
section 321(m) of this title. Nothing in the Convention on Psychotropic
Substances, signed at Vienna, Austria, on February 21, 1971, shall be construed
to prevent drug price communications to consumers.
- (o) Drugs or devices from nonregistered establishments
If it was manufactured, prepared, propagated, compounded, or processed in an
establishment in any State not duly registered under section 360 of this title,
if it was not included in a list required by section 360(j) of this title, if a
notice or other information respecting it was not provided as required by such
section or section 360(k) of this title, or if it does not bear such symbols
from the uniform system for identification of devices prescribed under section
360(e) of this title as the Secretary by regulation requires.
- (p) Packaging or labeling of drugs in violation of regulations
If it is a drug and its packaging or labeling is in violation of an
applicable regulation issued pursuant to section 1472 or 1473 of title 15.
- (q) Restricted devices using false or misleading advertising or
used in violation of regulations
In the case of any restricted device distributed or offered for sale in any
State, if (1) its advertising is false or misleading in any particular, or (2)
it is sold, distributed, or used in violation of regulations prescribed under
section 360j(e) of this title.
- (r) Restricted devices not carrying requisite accompanying
statements in advertisements and other descriptive printed matter
In the case of any restricted device distributed or offered for sale in any
State, unless the manufacturer, packer, or distributor thereof includes in all
advertisements and other descriptive printed matter issued or caused to be
issued by the manufacturer, packer, or distributor with respect to that device
(1) a true statement of the device's established name as defined in subsection
(e) of this section, printed prominently and in type at least half as large as
that used for any trade or brand name thereof, and (2) a brief statement of the
intended uses of the device and relevant warnings, precautions, side effects,
and contraindications and, in the case of specific devices made subject to a
finding by the Secretary after notice and opportunity for comment that such
action is necessary to protect the public health, a full description of the
components of such device or the formula showing quantitatively each ingredient
of such device to the extent required in regulations which shall be issued by
the Secretary after an opportunity for a hearing. Except in extraordinary
circumstances, no regulation issued under this paragraph shall require prior
approval by the Secretary of the content of any advertisement and no
advertisement of a restricted device, published after the effective date of this
paragraph shall, with respect to the matters specified in this paragraph or
covered by regulations issued hereunder, be subject to the provisions of
sections 52 through 55 of title 15. This paragraph shall not be applicable to
any printed matter which the Secretary determines to be labeling as defined in
section 321(m) of this title.
- (s) Devices subject to performance standards not bearing requisite
labeling
If it is a device subject to a performance standard established under
section 360d of this title, unless it bears such labeling as may be prescribed
in such performance standard.
- (t) Devices for which there has been a failure or refusal to give
required notification or to furnish required material or information
If it is a device and there was a failure or refusal (1) to comply with any
requirement prescribed under section 360h of this title respecting the device,
(2) to furnish any material or information required by or under section 360i of
this title respecting the device, or (3) to comply with a requirement under
section 360l of this title.
§ 353. Exemptions and consideration for certain drugs, devices,
and biological products.
- (a) Regulations for goods to be processed, labeled, or repacked
elsewhere
The Secretary is directed to promulgate regulations exempting from any
labeling or packaging requirement of this chapter drugs and devices which are,
in accordance with the practice of the trade, to be processed, labeled, or
repacked in substantial quantities at establishments other than those where
originally processed or packed, on condition that such drugs and devices are not
adulterated or misbranded under the provisions of this chapter upon removal from
such processing, labeling, or repacking establishment.
- (b) Prescription by physician; exemption from labeling and
prescription requirements; misbranded drugs; compliance with narcotic and
marihuana laws
- (1) A drug intended for use by man which -
- (A) is a habit-forming drug to which section 352(d) of this title applies;
or
- (B) because of its toxicity or other potentiality for harmful effect, or
the method of its use, or the collateral measures necessary to its use, is not
safe for use except under the supervision of a practitioner licensed by law to
administer such drug; or
- (C) is limited by an approved application under section 355 of this title
to use under the professional supervision of a practitioner licensed by law to
administer such drug; shall be dispensed only
- (i) upon a written prescription of a practitioner licensed by law to
administer such drug, or
- (ii) upon an oral prescription of such practitioner which is reduced
promptly to writing and filed by the pharmacist, or
- (iii) by refilling any such written or oral prescription if such refilling
is authorized by the prescriber either in the original prescription or by oral
order which is reduced promptly to writing and filed by the pharmacist. The act
of dispensing a drug contrary to the provisions of this paragraph shall be
deemed to be an act which results in the drug being misbranded while held for
sale.
- (2) Any drug dispensed by filling or refilling a written or oral
prescription of a practitioner licensed by law to administer such drug shall be
exempt from the requirements of section 352 of this title, except paragraphs
(a), (i)(2) and (3), (k), and (l), and the packaging requirements of paragraphs
(g), (h), and (p), if the drug bears a label containing the name and address of
the dispenser, the serial number and date of the prescription or of its filling,
the name of the prescriber, and, if stated in the prescription, the name of the
patient, and the directions for use and cautionary statements, if any, contained
in such prescription. This exemption shall not apply to any drug dispensed in
the course of the conduct of a business of dispensing drugs pursuant to
diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this
subsection.
- (3) The Secretary may by regulation remove drugs subject to sections 352(d)
and 355 of this title from the requirements of paragraph (1) of this subsection
when such requirements are not necessary for the protection of the public
health.
- (4) A drug which is subject to paragraph (1) of this subsection shall be
deemed to be misbranded if at any time prior to dispensing its label fails to
bear the statement ''Caution: Federal law prohibits dispensing without
prescription''. A drug to which paragraph (1) of this subsection does not apply
shall be deemed to be misbranded if at any time prior to dispensing its label
bears the caution statement quoted in the preceding sentence.
- (5) Nothing in this subsection shall be construed to relieve any person
from any requirement prescribed by or under authority of law with respect to
drugs now included or which may hereafter be included within the classifications
stated in sections 4721, 6001, and 6151 of title 26, or to marihuana as defined
in section 4761 of title 26.
- (c) Sales restrictions
- (1) No person may sell, purchase, or trade or offer to sell, purchase, or
trade any drug sample. For purposes of this paragraph and subsection (d) of this
section, the term ''drug sample'' means a unit of a drug, subject to subsection
(b) of this section, which is not intended to be sold and is intended to promote
the sale of the drug. Nothing in this paragraph shall subject an officer or
executive of a drug manufacturer or distributor to criminal liability solely
because of a sale, purchase, trade, or offer to sell, purchase, or trade in
violation of this paragraph by other employees of the manufacturer or
distributor.
- (2) No person may sell, purchase, or trade, offer to sell, purchase, or
trade, or counterfeit any coupon. For purposes of this paragraph, the term
''coupon'' means a form which may be redeemed, at no cost or at a reduced cost,
for a drug which is prescribed in accordance with subsection (b) of this
section.
- (3)
- (A) No person may sell, purchase, or trade, or offer to sell, purchase, or
trade, any drug -
- (i) which is subject to subsection (b) of this section, and
- (ii)
- (I) which was purchased by a public or private hospital or other health
care entity, or
- (II) which was donated or supplied at a reduced price to a charitable
organization described in section 501(c)(3) of title 26.
- (B) Subparagraph (A) does not apply to -
- (i) the purchase or other acquisition by a hospital or other health care
entity which is a member of a group purchasing organization of a drug for its
own use from the group purchasing organization or from other hospitals or health
care entities which are members of such organization,
- (ii) the sale, purchase, or trade of a drug or an offer to sell, purchase,
or trade a drug by an organization described in subparagraph (A)(ii)(II) to a
nonprofit affiliate of the organization to the extent otherwise permitted by
law,
- (iii) a sale, purchase, or trade of a drug or an offer to sell, purchase,
or trade a drug among hospitals or other health care entities which are under
common control,
- (iv) a sale, purchase, or trade of a drug or an offer to sell, purchase, or
trade a drug for emergency medical reasons, or
- (v) a sale, purchase, or trade of a drug, an offer to sell, purchase, or
trade a drug, or the dispensing of a drug pursuant to a prescription executed in
accordance with subsection (b) of this section. For purposes of this paragraph,
the term ''entity'' does not include a wholesale distributor of drugs or a
retail pharmacy licensed under State law and the term ''emergency medical
reasons'' includes transfers of a drug between health care entities or from a
health care entity to a retail pharmacy undertaken to alleviate temporary
shortages of the drug arising from delays in or interruptions of regular
distribution schedules.
- (d) Distribution of drug samples
- (1) Except as provided in paragraphs (2) and (3), no person may distribute
any drug sample. For purposes of this subsection, the term ''distribute'' does
not include the providing of a drug sample to a patient by a -
- (A) practitioner licensed to prescribe such drug,
- (B) health care professional acting at the direction and under the
supervision of such a practitioner, or
- (C) pharmacy of a hospital or of another health care entity that is acting
at the direction of such a practitioner and that received such sample pursuant
to paragraph (2) or (3).
- (2)
- (A) The manufacturer or authorized distributor of record of a drug subject
to subsection (b) of this section may, in accordance with this paragraph,
distribute drug samples by mail or common carrier to practitioners licensed to
prescribe such drugs or, at the request of a licensed practitioner, to
pharmacies of hospitals or other health care entities. Such a distribution of
drug samples may only be made -
- (i) in response to a written request for drug samples made on a form which
meets the requirements of subparagraph (B), and
- (ii) under a system which requires the recipient of the drug sample to
execute a written receipt for the drug sample upon its delivery and the return
of the receipt to the manufacturer or authorized distributor of record.
- (B) A written request for a drug sample required by subparagraph •(A)(i)
shall contain -
- (i) the name, address, professional designation, and signature of the
practitioner making the request,
- (ii) the identity of the drug sample requested and the quantity requested,
- (iii) the name of the manufacturer of the drug sample requested, and
- (iv) the date of the request.
- (C) Each drug manufacturer or authorized distributor of record which makes
distributions by mail or common carrier under this paragraph shall maintain, for
a period of 3 years, the request forms submitted for such distributions and the
receipts submitted for such distributions and shall maintain a record of
distributions of drug samples which identifies the drugs distributed and the
recipients of the distributions. Forms, receipts, and records required to be
maintained under this subparagraph shall be made available by the drug
manufacturer or authorized distributor of record to Federal and State officials
engaged in the regulation of drugs and in the enforcement of laws applicable to
drugs.
- (3) The manufacturer or authorized distributor of record of a drug subject
to subsection (b) of this section may, by means other than mail or common
carrier, distribute drug samples only if the manufacturer or authorized
distributor of record makes the distributions in accordance with subparagraph
(A) and carries out the activities described in subparagraphs (B) through (F) as
follows:
- (A) Drug samples may only be distributed -
- (i) to practitioners licensed to prescribe such drugs if they make a
written request for the drug samples, or
- (ii) at the written request of such a licensed practitioner, to pharmacies
of hospitals or other health care entities.
A written request for
drug samples shall be made on a form which contains the practitioner's name,
address, and professional designation, the identity of the drug sample
requested, the quantity of drug samples requested, the name of the manufacturer
or authorized distributor of record of the drug sample, the date of the request
and signature of the practitioner making the request.
- (B) Drug manufacturers or authorized distributors of record shall store
drug samples under conditions that will maintain their stability, integrity, and
effectiveness and will assure that the drug samples will be free of
contamination, deterioration, and adulteration.
- (C) Drug manufacturers or authorized distributors of record shall conduct,
at least annually, a complete and accurate inventory of all drug samples in the
possession of representatives of the manufacturer or authorized distributor of
record. Drug manufacturers or authorized distributors of record shall maintain
lists of the names and address of each of their representatives who distribute
drug samples and of the sites where drug samples are stored. Drug manufacturers
or authorized distributors of record shall maintain records for at least 3 years
of all drug samples distributed, destroyed, or returned to the manufacturer or
authorized distributor of record, of all inventories maintained under this
subparagraph, of all thefts or significant losses of drug samples, and of all
requests made under subparagraph (A) for drug samples. Records and lists
maintained under this subparagraph shall be made available by the drug
manufacturer or authorized distributor of record to the Secretary upon request.
- (D) Drug manufacturers or authorized distributors of record shall notify
the Secretary of any significant loss of drug samples and any known theft of
drug samples.
- (E) Drug manufacturers or authorized distributors of record shall report to
the Secretary any conviction of their representatives for violations of
subsection (c)(1) of this section or a State law because of the sale, purchase,
or trade of a drug sample or the offer to sell, purchase, or trade a drug
sample.
- (F) Drug manufacturers or authorized distributors of record shall provide
to the Secretary the name and telephone number of the individual responsible for
responding to a request for information respecting drug samples.
- (e) Wholesale distributors; guidelines for licensing; definitions
- (1)
- (A) Each person who is engaged in the wholesale distribution of a drug
subject to subsection (b) of this section and who is not the manufacturer or an
authorized distributor of record of such drug shall, before each wholesale
distribution of such drug (including each distribution to an authorized
distributor of record or to a retail pharmacy), provide to the person who
receives the drug a statement (in such form and containing such information as
the Secretary may require) identifying each prior sale, purchase, or trade of
such drug (including the date of the transaction and the names and addresses of
all parties to the transaction).
- (B) Each manufacturer of a drug subject to subsection (b) of this section
shall maintain at its corporate offices a current list of the authorized
distributors of record of such drug.
- (2)
- (A) No person may engage in the wholesale distribution in interstate
commerce of drugs subject to subsection (b) of this section in a State unless
such person is licensed by the State in accordance with the guidelines issued
under subparagraph (B).
- (B) The Secretary shall by regulation issue guidelines establishing minimum
standards, terms, and conditions for the licensing of persons to make wholesale
distributions in interstate commerce of drugs subject to subsection (b) of this
section. Such guidelines shall prescribe requirements for the storage and
handling of such drugs and for the establishment and maintenance of records of
the distributions of such drugs.
- (3) For the purposes of this subsection and subsection (d) of this section
-
- (A) the term ''authorized distributors of record'' means those distributors
with whom a manufacturer has established an ongoing relationship to distribute
such manufacturer's products, and
- (B) the term ''wholesale distribution'' means distribution of drugs subject
to subsection (b) of this section to other than the consumer or patient but does
not include intracompany sales and does not include distributions of drugs
described in subsection (c)(3)(B) of this section.
- (f) Veterinary prescription drugs
- (1)
- (A) A drug intended for use by animals other than man which -
- (i) because of its toxicity or other potentiality for harmful effect, or
the method of its use, or the collateral measures necessary for its use, is not
safe for animal use except under the professional supervision of a licensed
veterinarian, or
- (ii) is limited by an approved application under subsection (b) of section
360b of this title to use under the professional supervision of a licensed
veterinarian, shall be dispensed only by or upon the lawful written or oral
order of a licensed veterinarian in the course of the veterinarian's
professional practice.
- (B) For purposes of subparagraph (A), an order is lawful if the order -
- (i) is a prescription or other order authorized by law,
- (ii) is, if an oral order, promptly reduced to writing by the person
lawfully filling the order, and filed by that person, and
- (iii) is refilled only if authorized in the original order or in a
subsequent oral order promptly reduced to writing by the person lawfully filling
the order, and filed by that person.
- (C) The act of dispensing a drug contrary to the provisions of this
paragraph shall be deemed to be an act which results in the drug being
misbranded while held for sale.
- (2) Any drug when dispensed in accordance with paragraph (1) of this
subsection -
- (A) shall be exempt from the requirements of section 352 of this title,
except subsections (a), (g), (h), (i)(2), (i)(3), and (p) of such section, and
- (B) shall be exempt from the packaging requirements of subsections (g),
(h), and (p) of such section, if -
- (i) when dispensed by a licensed veterinarian, the drug bears a label
containing the name and address of the practitioner and any directions for use
and cautionary statements specified by the practitioner, or
- (ii) when dispensed by filling the lawful order of a licensed veterinarian,
the drug bears a label containing the name and address of the dispenser, the
serial number and date of the order or of its filling, the name of the licensed
veterinarian, and the directions for use and cautionary statements, if any,
contained in such order. The preceding sentence shall not apply to any drug
dispensed in the course of the conduct of a business of dispensing drugs
pursuant to diagnosis by mail.
- (3) The Secretary may by regulation exempt drugs for animals other than man
subject to section 360b of this title from the requirements of paragraph (1)
when such requirements are not necessary for the protection of the public
health.
- (4) A drug which is subject to paragraph (1) shall be deemed to be
misbranded if at any time prior to dispensing its label fails to bear the
statement ''Caution: Federal law restricts this drug to use by or on the order
of a licensed veterinarian.''. A drug to which paragraph (1) does not apply
shall be deemed to be misbranded if at any time prior to dispensing its label
bears the statement specified in the preceding sentence.
- (g) Regulation of combination products
- (1) The Secretary shall designate a component of the Food and Drug
Administration to regulate products that constitute a combination of a drug,
device, or biological product. The Secretary shall determine the primary mode of
action of the combination product. If the Secretary determines that the primary
mode of action is that of -
- (A) a drug (other than a biological product), the persons charged with
premarket review of drugs shall have primary jurisdiction,
- (B) a device, the persons charged with premarket review of devices shall
have primary jurisdiction, or
- (C) a biological product, the persons charged with premarket review of
biological products shall have primary jurisdiction.
- (2) Nothing in this subsection shall prevent the Secretary from using any
agency resources of the Food and Drug Administration necessary to ensure
adequate review of the safety, effectiveness, or substantial equivalence of an
article.
- (3) The Secretary shall promulgate regulations to implement market
clearance procedures in accordance with paragraphs (1) and (2) not later than 1
year after November 28, 1990.
- (4) As used in this subsection:
- (A) The term ''biological product'' has the meaning given the term in
section 262(a) of title 42.
- (B) The term ''market clearance'' includes -
- (i) approval of an application under section 355, 357, 360e, or 360j(g) of
this title,
- (ii) a finding of substantial equivalence under this part, and
- (iii) approval of a product or establishment license under subsection (a)
or (d) of section 262 of title 42.
§ 354. Repealed.
§ 354. Repealed. Pub. L. 86-618, title I, Sec. 103(a)(2), July 12,
1960, 74 Stat. 398
§ 355. New drugs.
- (a) Necessity of effective approval of application
No person shall introduce or deliver for introduction into interstate
commerce any new drug, unless an approval of an application filed pursuant to
subsection (b) or (j) of this section is effective with respect to such drug.
- (b) Filing application; contents
- (1) Any person may file with the Secretary an application with respect to
any drug subject to the provisions of subsection (a) of this section. Such
person shall submit to the Secretary as a part of the application
- (A) full reports of investigations which have been made to show whether or
not such drug is safe for use and whether such drug is effective in use;
- (B) a full list of the articles used as components of such drug;
- (C) a full statement of the composition of such drug;
- (D) a full description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing of such drug;
- (E) such samples of such drug and of the articles used as components
thereof as the Secretary may require; and
- (F) specimens of the labeling proposed to be used for such drug. The
applicant shall file with the application the patent number and the expiration
date of any patent which claims the drug for which the applicant submitted the
application or which claims a method of using such drug and with respect to
which a claim of patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture, use, or sale of the drug.
If an application is filed under this subsection for a drug and a patent which
claims such drug or a method of using such drug is issued after the filing date
but before approval of the application, the applicant shall amend the
application to include the information required by the preceding sentence. Upon
approval of the application, the Secretary shall publish information submitted
under the two preceding sentences.
- (2) An application submitted under paragraph (1) for a drug for which the
investigations described in clause (A) of such paragraph and relied upon by the
applicant for approval of the application were not conducted by or for the
applicant and for which the applicant has not obtained a right of reference or
use from the person by or for whom the investigations were conducted shall also
include -
- (A) a certification, in the opinion of the applicant and to the best of his
knowledge, with respect to each patent which claims the drug for which such
investigations were conducted or which claims a use for such drug for which the
applicant is seeking approval under this subsection and for which information is
required to be filed under paragraph (1) or subsection (c) of this section -
- (i) that such patent information has not been filed,
- (ii) that such patent has expired,
- (iii) of the date on which such patent will expire, or
- (iv) that such patent is invalid or will not be infringed by the
manufacture, use, or sale of the new drug for which the application is
submitted; and
- (B) if with respect to the drug for which investigations described in
paragraph (1)(A) were conducted information was filed under paragraph (1) or
subsection (c) of this section for a method of use patent which does not claim a
use for which the applicant is seeking approval under this subsection, a
statement that the method of use patent does not claim such a use.
- (3)
- (A) An applicant who makes a certification described in paragraph
(2)(A)(iv) shall include in the application a statement that the applicant will
give the notice required by subparagraph (B) to -
- (i) each owner of the patent which is the subject of the certification or
the representative of such owner designated to receive such notice, and
- (ii) the holder of the approved application under subsection (b) of this
section for the drug which is claimed by the patent or a use of which is claimed
by the patent or the representative of such holder designated to receive such
notice.
- (B) The notice referred to in subparagraph (A) shall state that an
application has been submitted under this subsection for the drug with respect
to which the certification is made to obtain approval to engage in the
commercial manufacture, use, or sale of the drug before the expiration of the
patent referred to in the certification. Such notice shall include a detailed
statement of the factual and legal basis of the applicant's opinion that the
patent is not valid or will not be infringed.
- (C) If an application is amended to include a certification described in
paragraph (2)(A)(iv), the notice required by subparagraph (B) shall be given
when the amended application is submitted.
- (c) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order
- (1) Within one hundred and eighty days after the filing of an application
under subsection (b) of this section, or such additional period as may be agreed
upon by the Secretary and the applicant, the Secretary shall either -
- (A) approve the application if he then finds that none of the grounds for
denying approval specified in subsection (d) of this section applies, or
- (B) give the applicant notice of an opportunity for a hearing before the
Secretary under subsection (d) of this section on the question whether such
application is approvable. If the applicant elects to accept the opportunity for
hearing by written request within thirty days after such notice, such hearing
shall commence not more than ninety days after the expiration of such thirty
days unless the Secretary and the applicant otherwise agree. Any such hearing
shall thereafter be conducted on an expedited basis and the Secretary's order
thereon shall be issued within ninety days after the date fixed by the Secretary
for filing final briefs.
- (2) If the patent information described in subsection (b) of this section
could not be filed with the submission of an application under subsection (b) of
this section because the application was filed before the patent information was
required under subsection (b) of this section or a patent was issued after the
application was approved under such subsection, the holder of an approved
application shall file with the Secretary the patent number and the expiration
date of any patent which claims the drug for which the application was submitted
or which claims a method of using such drug and with respect to which a claim of
patent infringement could reasonably be asserted if a person not licensed by the
owner engaged in the manufacture, use, or sale of the drug. If the holder of an
approved application could not file patent information under subsection (b) of
this section because it was not required at the time the application was
approved, the holder shall file such information under this subsection not later
than thirty days after September 24, 1984, and if the holder of an approved
application could not file patent information under subsection (b) of this
section because no patent had been issued when an application was filed or
approved, the holder shall file such information under this subsection not later
than thirty days after the date the patent involved is issued. Upon the
submission of patent information under this subsection, the Secretary shall
publish it.
- (3) The approval of an application filed under subsection (b) of this
section which contains a certification required by paragraph (2) of such
subsection shall be made effective on the last applicable date determined under
the following:
- (A) If the applicant only made a certification described in clause (i) or
(ii) of subsection (b)(2)(A) of this section or in both such clauses, the
approval may be made effective immediately.
- (B) If the applicant made a certification described in clause (iii) of
subsection (b)(2)(A) of this section, the approval may be made effective on the
date certified under clause (iii).
- (C) If the applicant made a certification described in clause (iv) of
subsection (b)(2)(A) of this section, the approval shall be made effective
immediately unless an action is brought for infringement of a patent which is
the subject of the certification before the expiration of forty-five days from
the date the notice provided under paragraph (3)(B) is received. If such an
action is brought before the expiration of such days, the approval may be made
effective upon the expiration of the thirty-month period beginning on the date
of the receipt of the notice provided under paragraph (3)(B) or such shorter or
longer period as the court may order because either party to the action failed
to reasonably cooperate in expediting the action, except that -
- (i) if before the expiration of such period the court decides that such
patent is invalid or not infringed, the approval may be made effective on the
date of the court decision,
- (ii) if before the expiration of such period the court decides that such
patent has been infringed, the approval may be made effective on such date as
the court orders under section 271(e)(4)(A) of title 35, or
- (iii) if before the expiration of such period the court grants a
preliminary injunction prohibiting the applicant from engaging in the commercial
manufacture or sale of the drug until the court decides the issues of patent
validity and infringement and if the court decides that such patent is invalid
or not infringed, the approval shall be made effective on the date of such court
decision.
In such an action, each of the parties shall
reasonably cooperate in expediting the action. Until the expiration of
forty-five days from the date the notice made under paragraph (3)(B) is
received, no action may be brought under section 2201 of title 28 for a
declaratory judgment with respect to the patent. Any action brought under such
section 2201 shall be brought in the judicial district where the defendant has
its principal place of business or a regular and established place of business.
- (D)
- (i) If an application (other than an abbreviated new drug application)
submitted under subsection (b) of this section for a drug, no active ingredient
(including any ester or salt of the active ingredient) of which has been
approved in any other application under subsection (b) of this section, was
approved during the period beginning January 1, 1982, and ending on September
24, 1984, the Secretary may not make the approval of another application for a
drug for which the investigations described in clause (A) of subsection (b)(1)
of this section and relied upon by the applicant for approval of the application
were not conducted by or for the applicant and for which the applicant has not
obtained a right of reference or use from the person by or for whom the
investigations were conducted effective before the expiration of ten years from
the date of the approval of the application previously approved under subsection
(b) of this section.
- (ii) If an application submitted under subsection (b) of this section for a
drug, no active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application under subsection
(b) of this section, is approved after September 24, 1984, no application which
refers to the drug for which the subsection (b) application was submitted and
for which the investigations described in clause (A) of subsection (b)(1) of
this section and relied upon by the applicant for approval of the application
were not conducted by or for the applicant and for which the applicant has not
obtained a right of reference or use from the person by or for whom the
investigations were conducted may be submitted under subsection (b) of this
section before the expiration of five years from the date of the approval of the
application under subsection (b) of this section, except that such an
application may be submitted under subsection (b) of this section after the
expiration of four years from the date of the approval of the subsection (b)
application if it contains a certification of patent invalidity or
noninfringement described in clause (iv) of subsection (b)(2)(A) of this
section. The approval of such an application shall be made effective in
accordance with this paragraph except that, if an action for patent infringement
is commenced during the one-year period beginning forty-eight months after the
date of the approval of the subsection (b) application, the thirty-month period
referred to in subparagraph (C) shall be extended by such amount of time (if
any) which is required for seven and one-half years to have elapsed from the
date of approval of the subsection (b) application.
- (iii) If an application submitted under subsection (b) of this section for
a drug, which includes an active ingredient (including any ester or salt of the
active ingredient) that has been approved in another application approved under
subsection (b) of this section, is approved after September 24, 1984, and if
such application contains reports of new clinical investigations (other than
bioavailability studies) essential to the approval of the application and
conducted or sponsored by the applicant, the Secretary may not make the approval
of an application submitted under subsection (b) of this section for the
conditions of approval of such drug in the approved subsection (b) application
effective before the expiration of three years from the date of the approval of
the application under subsection (b) of this section if the investigations
described in clause (A) of subsection (b)(1) of this section and relied upon by
the applicant for approval of the application were not conducted by or for the
applicant and if the applicant has not obtained a right of reference or use from
the person by or for whom the investigations were conducted.
- (iv) If a supplement to an application approved under subsection (b) of
this section is approved after September 24, 1984, and the supplement contains
reports of new clinical investigations (other than bioavailabilty (FOOTNOTE 1)
studies) essential to the approval of the supplement and conducted or sponsored
by the person submitting the supplement, the Secretary may not make the approval
of an application submitted under subsection (b) of this section for a change
approved in the supplement effective before the expiration of three years from
the date of the approval of the supplement under subsection (b) of this section
if the investigations described in clause (A) of subsection (b)(1) of this
section and relied upon by the applicant for approval of the application were
not conducted by or for the applicant and if the applicant has not obtained a
right of reference or use from the person by or for whom the investigations were
conducted. (FOOTNOTE 1) So in original. Probably should be
''bioavailability''.
- (v) If an application (or supplement to an application) submitted under
subsection (b) of this section for a drug, which includes an active ingredient
(including any ester or salt of the active ingredient) that has been approved in
another application under subsection (b) of this section, was approved during
the period beginning January 1, 1982, and ending on September 24, 1984, the
Secretary may not make the approval of an application submitted under this
subsection and for which the investigations described in clause (A) of
subsection (b)(1) of this section and relied upon by the applicant for approval
of the application were not conducted by or for the applicant and for which the
applicant has not obtained a right of reference or use from the person by or for
whom the investigations were conducted and which refers to the drug for which
the subsection (b) application was submitted effective before the expiration of
two years from September 24, 1984.
- (d) Grounds for refusing application; approval of application;
''substantial evidence'' defined
If the Secretary finds, after due notice to the applicant in accordance with
subsection (c) of this section and giving him an opportunity for a hearing, in
accordance with said subsection, that
- (1) the investigations, reports of which are required to be submitted
to the Secretary pursuant to subsection (b) of this section, do not include
adequate tests by all methods reasonably applicable to show whether or not such
drug is safe for use under the conditions prescribed, recommended, or suggested
in the proposed labeling thereof;
- (2) the results of such tests show that such drug is unsafe for use under
such conditions or do not show that such drug is safe for use under such
conditions;
- (3) the methods used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug are inadequate to preserve its
identity, strength, quality, and purity;
- (4) upon the basis of the information submitted to him as part of the
application, or upon the basis of any other information before him with respect
to such drug, he has insufficient information to determine whether such drug is
safe for use under such conditions; or
- (5) evaluated on the basis of the information submitted to him as part of
the application and any other information before him with respect to such drug,
there is a lack of substantial evidence that the drug will have the effect it
purports or is represented to have under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof; or
- (6) the application failed to contain the patent information prescribed by
subsection (b) of this section; or
- (7) based on a fair evaluation of all material facts, such labeling is
false or misleading in any particular; he shall issue an order refusing to
approve the application.
If, after such notice and opportunity for hearing, the Secretary finds that
clauses (1) through (6) do not apply, he shall issue an order approving the
application. As used in this subsection and subsection (e) of this section, the
term ''substantial evidence'' means evidence consisting of adequate and
well-controlled investigations, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the effectiveness of
the drug involved, on the basis of which it could fairly and responsibly be
concluded by such experts that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof.
- (e) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to public health
The Secretary shall, after due notice and opportunity for hearing to the
applicant, withdraw approval of an application with respect to any drug under
this section if the Secretary finds
- (1) that clinical or other experience, tests, or other scientific data
show that such drug is unsafe for use under the conditions of use upon the basis
of which the application was approved;
- (2) that new evidence of clinical experience, not contained in such
application or not available to the Secretary until after such application was
approved, or tests by new methods, or tests by methods not deemed reasonably
applicable when such application was approved, evaluated together with the
evidence available to the Secretary when the application was approved, shows
that such drug is not shown to be safe for use under the conditions of use upon
the basis of which the application was approved; or
- (3) on the basis of new information before him with respect to such drug,
evaluated together with the evidence available to him when the application was
approved, that there is a lack of substantial evidence that the drug will have
the effect it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling thereof; or
- (4) the patent information prescribed by subsection (c) of this section was
not filed within thirty days after the receipt of written notice from the
Secretary specifying the failure to file such information; or
- (5) that the application contains any untrue statement of a material fact:
Provided, That if the Secretary (or in his absence the officer acting as
Secretary) finds that there is an imminent hazard to the public health, he may
suspend the approval of such application immediately, and give the applicant
prompt notice of his action and afford the applicant the opportunity for an
expedited hearing under this subsection; but the authority conferred by this
proviso to suspend the approval of an application shall not be delegated.
The Secretary may also, after due notice and opportunity for hearing to the
applicant, withdraw the approval of an application submitted under subsection
(b) or (j) of this section with respect to any drug under this section if the
Secretary finds (1) that the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately failed to
maintain such records or to make required reports, in accordance with a
regulation or order under subsection (k) of this section or to comply with the
notice requirements of section 360(k)(2) of this title, or the applicant has
refused to permit access to, or copying or verification of, such records as
required by paragraph (2) of such subsection; or (2) that on the basis of new
information before him, evaluated together with the evidence before him when the
application was approved, the methods used in, or the facilities and controls
used for, the manufacture, processing, and packing of such drug are inadequate
to assure and preserve its identity, strength, quality, and purity and were not
made adequate within a reasonable time after receipt of written notice from the
Secretary specifying the matter complained of; or (3) that on the basis of new
information before him, evaluated together with the evidence before him when the
application was approved, the labeling of such drug, based on a fair evaluation
of all material facts, is false or misleading in any particular and was not
corrected within a reasonable time after receipt of written notice from the
Secretary specifying the matter complained of. Any order under this subsection
shall state the findings upon which it is based.
- (f) Revocation of order refusing, withdrawing or suspending
approval of application
Whenever the Secretary finds that the facts so require, he shall revoke any
previous order under subsection (d) or (e) of this section refusing,
withdrawing, or suspending approval of an application and shall approve such
application or reinstate such approval, as may be appropriate.
Orders of the Secretary issued under this section shall be served
- (1) in person by any officer or employee of the department designated
by the Secretary or
- (2) by mailing the order by registered mail or by certified mail addressed
to the applicant or respondent at his last-known address in the records of the
Secretary.
An appeal may be taken by the applicant from an order of the Secretary
refusing or withdrawing approval of an application under this section. Such
appeal shall be taken by filing in the United States court of appeals or the
circuit wherein such applicant resides or has his principal place of business,
or in the United States Court of Appeals for the District of Columbia Circuit,
within sixty days after the entry of such order, a written petition praying that
the order of the Secretary be set aside. A copy of such petition shall be
forthwith transmitted by the clerk of the court to the Secretary, or any officer
designated by him for that purpose, and thereupon the Secretary shall certify
and file in the court the record upon which the order complained of was entered,
as provided in section 2112 of title 28. Upon the filing of such petition such
court shall have exclusive jurisdiction to affirm or set aside such order,
except that until the filing of the record the Secretary may modify or set aside
his order. No objection to the order of the Secretary shall be considered by the
court unless such objection shall have been urged before the Secretary or unless
there were reasonable grounds for failure so to do. The finding of the Secretary
as to the facts, if supported by substantial evidence, shall be conclusive. If
any person shall apply to the court for leave to adduce additional evidence, and
shall show to the satisfaction of the court that such additional evidence is
material and that there were reasonable grounds for failure to adduce such
evidence in the proceeding before the Secretary, the court may order such
additional evidence to be taken before the Secretary and to be adduced upon the
hearing in such manner and upon such terms and conditions as to the court may
seem proper. The Secretary may modify his findings as to the facts by reason of
the additional evidence so taken, and he shall file with the court such modified
findings which, if supported by substantial evidence, shall be conclusive, and
his recommendation, if any, for the setting aside of the original order. The
judgment of the court affirming or setting aside any such order of the Secretary
shall be final, subject to review by the Supreme Court of the United States upon
certiorari or certification as provided in section 1254 of title 28. The
commencement of proceedings under this subsection shall not, unless specifically
ordered by the court to the contrary, operate as a stay of the Secretary's
order.
- (i) Exemptions of drugs for research; discretionary and mandatory
conditions; direct reports to Secretary
The Secretary shall promulgate regulations for exempting from the operation
of the foregoing subsections of this section drugs intended solely for
investigational use by experts qualified by scientific training and experience
to investigate the safety and effectiveness of drugs. Such regulations may,
within the discretion of the Secretary, among other conditions relating to the
protection of the public health, provide for conditioning such exemption upon -
- (1) the submission to the Secretary, before any clinical testing of a
new drug is undertaken, of reports, by the manufacturer or the sponsor of the
investigation of such drug, of preclinical tests (including tests on animals) of
such drug adequate to justify the proposed clinical testing;
- (2) the manufacturer or the sponsor of the investigation of a new drug
proposed to be distributed to investigators for clinical testing obtaining a
signed agreement from each of such investigators that patients to whom the drug
is administered will be under his personal supervision, or under the supervision
of investigators responsible to him, and that he will not supply such drug to
any other investigator, or to clinics, for administration to human beings; and
- (3) the establishment and maintenance of such records, and the making of
such reports to the Secretary, by the manufacturer or the sponsor of the
investigation of such drug, of data (including but not limited to analytical
reports by investigators) obtained as the result of such investigational use of
such drug, as the Secretary finds will enable him to evaluate the safety and
effectiveness of such drug in the event of the filing of an application pursuant
to subsection (b) of this section.
Such regulations shall provide that such exemption shall be conditioned upon
the manufacturer, or the sponsor of the investigation, requiring that experts
using such drugs for investigational purposes certify to such manufacturer or
sponsor that they will inform any human beings to whom such drugs, or any
controls used in connection therewith, are being administered, or their
representatives, that such drugs are being used for investigational purposes and
will obtain the consent of such human beings or their representatives, except
where they deem it not feasible or, in their professional judgment, contrary to
the best interests of such human beings. Nothing in this subsection shall be
construed to require any clinical investigator to submit directly to the
Secretary reports on the investigational use of drugs.
- (j) Abbreviated new drug applications
- (k) Records and reports; required information; regulations and
orders; access to records
- (1) In the case of any drug for which an approval of an application filed
under subsection (b) or (j) of this section is in effect, the applicant shall
establish and maintain such records, and make such reports to the Secretary, of
data relating to clinical experience and other data or information, received or
otherwise obtained by such applicant with respect to such drug, as the Secretary
may by general regulation, or by order with respect to such application,
prescribe on the basis of a finding that such records and reports are necessary
in order to enable the Secretary to determine, or facilitate a determination,
whether there is or may be ground for invoking subsection (e) of this section.
Regulations and orders issued under this subsection and under subsection (i) of
this section shall have due regard for the professional ethics of the medical
profession and the interests of patients and shall provide, where the Secretary
deems it to be appropriate, for the examination, upon request, by the persons to
whom such regulations or orders are applicable, of similar information received
or otherwise obtained by the Secretary.
- (2) Every person required under this section to maintain records, and every
person in charge or custody thereof, shall, upon request of an officer or
employee designated by the Secretary, permit such officer or employee at all
reasonable times to have access to and copy and verify such records.
- (l) Public disclosure of safety and effectiveness data
Safety and effectiveness data and information which has been submitted in an
application under subsection (b) of this section for a drug and which has not
previously been disclosed to the public shall be made available to the public,
upon request, unless extraordinary circumstances are shown -
- (1) if no work is being or will be undertaken to have the application
approved,
- (2) if the Secretary has determined that the application is not approvable
and all legal appeals have been exhausted,
- (3) if approval of the application under subsection (c) of this section is
withdrawn and all legal appeals have been exhausted,
- (4) if the Secretary has determined that such drug is not a new drug, or
- (5) upon the effective date of the approval of the first application under
subsection (j) of this section which refers to such drug or upon the date upon
which the approval of an application under subsection (j) of this section which
refers to such drug could be made effective if such an application had been
submitted.
For purposes of this section, the term ''patent'' means a patent issued by
the Patent and Trademark Office of the Department of Commerce.
§ 356. Certification of drugs containing insulin.
- (a) Standards for certification
The Secretary, pursuant to regulations promulgated by him, shall provide for
the certification of batches of drugs composed wholly or partly of insulin. A
batch of any such drug shall be certified if such drug has such characteristics
of identity and such batch has such characteristics of strength, quality, and
purity, as the Secretary prescribes in such regulations as necessary to
adequately insure safety and efficacy of use, but shall not otherwise be
certified. Prior to the effective date of such regulations the Secretary, in
lieu of certification, shall issue a release for any batch which, in his
judgment, may be released without risk as to the safety and efficacy of its use.
Such release shall prescribe the date of its expiration and other conditions
under which it shall cease to be effective as to such batch and as to portions
thereof.
Regulations providing for such certification shall contain such provisions
as are necessary to carry out the purposes of this section, including provisions
prescribing (1) standards of identity and of strength, quality, and purity; (2)
tests and methods of assay to determine compliance with such standards; (3)
effective periods for certificates, and other conditions under which they shall
cease to be effective as to certified batches and as to portions thereof; (4)
administration and procedure; and (5) such fees, specified in such regulations,
as are necessary to provide, equip, and maintain an adequate certification
service. Such regulations shall prescribe no standard of identity or of
strength, quality, or purity for any drug different from the standard of
identity, strength, quality, or purity set forth for such drug in an official
compendium.
- (c) Tests or methods of assay; revision
Such regulations, insofar as they prescribe tests or methods of assay to
determine strength, quality, or purity of any drug, different from the tests or
methods of assay set forth for such drug in an official compendium, shall be
prescribed, after notice and opportunity for revision of such compendium, in the
manner provided in the second sentence of section 351(b) of this title. The
provisions of subsections (e), (f), and (g) of section 371 of this title shall
be applicable to such portion of any regulation as prescribes any such different
test or method, but shall not be applicable to any other portion of any such
regulation.
§ 357. Certification of drugs containing penicillin, streptomycin,
chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug.
- (a) Regulations prescribed by Secretary; release prior to
certification; ''antibiotic drug'' defined
The Secretary, pursuant to regulations promulgated by him, shall provide for
the certification of batches of drugs (except drugs for use in animals other
than man) composed wholly or partly of any kind of penicillin, streptomycin,
chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or
any derivative thereof. A batch of any such drug shall be certified if such drug
has such characteristics of identity and such batch has such characteristics of
strength, quality, and purity, as the Secretary prescribes in such regulations
as necessary to adequately insure safety and efficacy of use, but shall not
otherwise be certified. Prior to the effective date of such regulations the
Secretary, in lieu of certification, shall issue a release for any batch which,
in his judgment, may be released without risk as to the safety and efficacy of
its use. Such release shall prescribe the date of its expiration and other
conditions under which it shall cease to be effective as to such batch and as to
portions thereof. For purposes of this section and of section 352(l) of this
title, the term ''antibiotic drug'' means any drug intended for use by man
containing any quantity of any chemical substance which is produced by a
microorganism and which has the capacity to inhibit or destroy microorganisms in
dilute solution (including the chemically synthesized equivalent of any such
substance).
- (b) Provisions of regulations
Regulations providing for such certifications shall contain such provisions
as are necessary to carry out the purposes of this section, including provisions
prescribing (1) standards of identity and of strength, quality, and purity; (2)
tests and methods of assay to determine compliance with such standards; (3)
effective periods for certificates, and other conditions under which they shall
cease to be effective as to certified batches and as to portions thereof; (4)
administration and procedure; and (5) such fees, specified in such regulations,
as are necessary to provide, equip, and maintain an adequate certification
service. Such regulations shall prescribe only such tests and methods of assay
as will provide for certification or rejection within the shortest time
consistent with the purposes of this section.
- (c) Exemption of drugs not involving safety and efficacy of use;
considerations; certification after exemption; labeling and advertising claims
Whenever in the judgment of the Administrator, (FOOTNOTE 1) the requirements
of this section and of section 352(l) of this title with respect to any drug or
class of drugs are not necessary to insure safety and efficacy of use, the
Administrator (FOOTNOTE 1) shall promulgate regulations exempting such drug or
class of drugs from such requirements. In deciding whether an antibiotic drug,
or class of antibiotic drugs, is to be exempted from the requirement of
certification the Secretary shall give consideration, among other relevant
factors, to - (FOOTNOTE 1) See Transfer of Functions note below.
- (1) whether such drug or class of drugs is manufactured by a person
who has, or hereafter shall have, produced fifty consecutive batches of such
drug or class of drugs in compliance with the regulations for the certification
thereof within a period of not more than eighteen calendar months, upon the
application by such person to the Secretary; or
- (2) whether such drug or class of drugs is manufactured by any person who
has otherwise demonstrated such consistency in the production of such drug or
class of drugs, in compliance with the regulations for the certification
thereof, as in the judgment of the Secretary is adequate to insure the safety
and efficacy of use thereof.
When an antibiotic drug or a drug manufacturer has been exempted from the
requirement of certification, the manufacturer may still obtain certification of
a batch or batches of that drug if he applies for and meets the requirements for
certification. Nothing in this chapter shall be deemed to prevent a manufacturer
or distributor of an antibiotic drug from making a truthful statement in
labeling or advertising of the product as to whether it has been certified or
exempted from the requirement of certification.
- (d) Exemption of drugs stored, processed, and labeled at plants
other than manufacturer's, used in manufacture of other drugs or for
investigational purposes; discretionary and mandatory conditions; direct reports
to Secretary
The Administrator (FOOTNOTE 1) shall promulgate regulations exempting from
any requirement of this section and of section 352(l) of this title, (1) drugs
which are to be stored, processed, labeled, or repacked at establishments other
than those where manufactured, on condition that such drugs comply with all such
requirements upon removal from such establishments; (2) drugs which conform to
applicable standards of identity, strength, quality, and purity prescribed by
these regulations and are intended for use in manufacturing other drugs; and (3)
drugs which are intended solely for investigational use by experts qualified by
scientific training and experience to investigate the safety and efficacy of
drugs. Such regulations may, within the discretion of the Secretary, among other
conditions relating to the protection of the public health, provide for
conditioning the exemption under clause (3) of this subsection upon -
- (1) the submission to the Secretary, before any clinical testing of a
new drug is undertaken, of reports, by the manufacturer or the sponsor of the
investigation of such drug, of preclinical tests (including tests on animals) of
such drug adequate to justify the proposed clinical testing;
- (2) the manufacturer or the sponsor of the investigation of a new drug
proposed to be distributed to investigators for clinical testing obtaining a
signed agreement from each of such investigators that patients to whom the drug
is administered will be under his personal supervision, or under the supervision
of investigators responsible to him, and that he will not supply such drug to
any other investigator, or to clinics, for administration to human beings; and
- (3) the establishment and maintenance of such records, and the making of
such reports to the Secretary, by the manufacturer or the sponsor of the
investigation of such drug, of data (including but not limited to analytical
reports by investigators) obtained as the result of such investigational use of
such drug, as the Secretary finds will enable him to evaluate the safety and
effectiveness of such drug in the event of the filing of an application for
certification or release pursuant to subsection (a) of this section.
Such regulations shall provide that such exemption shall be conditioned
upon the manufacturer, or the sponsor of the investigation, requiring that
experts using such drugs for investigational purposes certify to such
manufacturer or sponsor that they will inform any human beings to whom such
drugs, or any controls used in connection therewith, are being administered, or
their representatives, that such drugs are being used for investigational
purposes and will obtain the consent of such human beings or their
representatives, except where they deem it not feasible or, in their
professional judgment, contrary to the best interests of such human beings.
Nothing in this subsection shall be construed to require any clinical
investigator to submit directly to the Secretary reports on the investigational
use of drugs.
- (e) Exempted new drugs subject to section 355 of this title;
request for certification of exempted drug; determination of compliance with
sections 351(b) and 352(g) of this title
No drug which is subject to this section shall be deemed to be subject to
any provision of section 355 of this title except a new drug exempted from the
requirements of this section and of section 352(l) of this title pursuant to
regulations promulgated by the Secretary. For purposes of section 355 of this
title, the initial request for certification, as thereafter duly amended,
pursuant to this section, of a new drug so exempted shall be considered a part
of the application filed pursuant to section 355(b) of this title with respect
to the person filing such request and to such drug as of the date of the
exemption. Compliance of any drug subject to section 352(l) of this title or
this section with sections 351(b) and 352(g) of this title shall be determined
by the application of the standards of strength, quality, and purity, the tests
and methods of assay, and the requirements of packaging and labeling,
respectively, prescribed by regulations promulgated under this section.
- (f) Filing of petitions; contents; notice; answer; public hearing;
orders
Any interested person may file with the Administrator (FOOTNOTE 2) a
petition proposing the issuance, amendment, or repeal of any regulation
contemplated by this section. The petition shall set forth the proposal in
general terms and shall state reasonable grounds therefor. The Administrator
(FOOTNOTE 2) shall give public notice of the proposal and an opportunity for all
interested persons to present their views thereon, orally or in writing, and as
soon as practicable thereafter shall make public his action upon such proposal.
At any time prior to the thirtieth day after such action is made public any
interested person may file objections to such action, specifying with
particularity the changes desired, stating reasonable grounds therefor, and
requesting a public hearing upon such objections. The Administrator (FOOTNOTE 2)
shall thereupon, after due notice, hold such public hearing. As soon as
practicable after completion of the hearing, the Administrator (FOOTNOTE 2)
shall by order make public his action on such objections. The Administrator
(FOOTNOTE 2) shall base his order only on substantial evidence of record at the
hearing and shall set forth as part of the order detailed findings of fact on
which the order is based. The order shall be subject to the provisions of
section 371(f) and (g) of this title. (FOOTNOTE 2) See Transfer of Functions
note below.
- (g) Records and reports; professional ethics and interests of
patients; examination of data; access to records
- (1) Every person engaged in manufacturing, compounding, or processing any
drug within the purview of this section with respect to which a certificate or
release has been issued pursuant to this section shall establish and maintain
such records, and make such reports to the Secretary, of data relating to
clinical experience and other data or information, received or otherwise
obtained by such person with respect to such drug, as the Secretary may by
general regulation, or by order with respect to such certification or release,
prescribe on the basis of a finding that such records and reports are necessary
in order to enable the Secretary to make, or to facilitate, a determination as
to whether such certification or release should be rescinded or whether any
regulation issued under this section should be amended or repealed. Regulations
and orders issued under this subsection and under clause (3) of subsection (d)
of this section shall have due regard for the professional ethics of the medical
profession and the interests of patients and shall provide, where the Secretary
deems it to be appropriate, for the examination, upon request, by the persons to
whom such regulations or orders are applicable, of similar information received
or otherwise obtained by the Secretary.
- (2) Every person required under this section to maintain records, and every
person having charge or custody thereof, shall, upon request of an officer or
employee designated by the Secretary, permit such officer or employee at all
reasonable times to have access to and copy and verify such records.
- (h) Issuance of regulations; conditions; amendment or repeal of
regulations; effective date; procedure; lack of substantial evidence
In the case of a drug for which, on the day immediately preceding May 1,
1963, a prior approval of an application under section 355 of this title had not
been withdrawn under section 355(e) of this title, the initial issuance of
regulations providing for certification or exemption of such drug under this
section shall, with respect to the conditions of use prescribed, recommended, or
suggested in the labeling covered by such application, not be conditioned upon
an affirmative finding of the efficacy of such drug. Any subsequent amendment or
repeal of such regulations so as no longer to provide for such certification or
exemption on the ground of a lack of efficacy of such drug for use under such
conditions of use may be effected only on or after May 1, 1963, which would be
applicable to such drug under such conditions of use if such drug were subject
to section 355(e) of this title, and then only if (1) such amendment or repeal
is made in accordance with the procedure specified in subsection (f) of this
section (except that such amendment or repeal may be initiated either by a
proposal of the Secretary or by a petition of any interested person) and (2) the
Secretary finds, on the basis of new information with respect to such drug
evaluated together with the information before him when the application under
section 355 of this title became effective or was approved, that there is a lack
of substantial evidence (as defined in section 355(d) of this title) that the
drug has the effect it purports or is represented to have under such conditions
of use.
§ 358. Authority to designate official names.
- (a) Necessity or desirability; use in official compendiums;
infringement of trademarks
The Secretary may designate an official name for any drug or device if he
determines that such action is necessary or desirable in the interest of
usefulness and simplicity. Any official name designated under this section for
any drug or device shall be the only official name of that drug or device used
in any official compendium published after such name has been prescribed or for
any other purpose of this chapter. In no event, however, shall the Secretary
establish an official name so as to infringe a valid trademark.
- (b) Review of names in official compendiums
Within a reasonable time after October 10, 1962, and at such other times as
he may deem necessary, the Secretary shall cause a review to be made of the
official names by which drugs are identified in the official United States
Pharmacopoeia, the official Homoeopathic Pharmacopoeia of the United States, and
the official National Formulary, and all supplements thereto, and at such times
as he may deem necessary shall cause a review to be made of the official names
by which devices are identified in any official compendium (and all supplements
thereto) to determine whether revision of any of those names is necessary or
desirable in the interest of usefulness and simplicity.
- (c) Determinations of complexity, usefulness, multiplicity, or
lack of name; designation by Secretary
Whenever he determines after any such review that (1) any such official name
is unduly complex or is not useful for any other reason, (2) two or more
official names have been applied to a single drug or device, or to two or more
drugs which are identical in chemical structure and pharmacological action and
which are substantially identical in strength, quality, and purity, or to two or
more devices which are substantially equivalent in design and purpose or (3) no
official name has been applied to a medically useful drug or device, he shall
transmit in writing to the compiler of each official compendium in which that
drug or drugs or device are identified and recognized his request for the
recommendation of a single official name for such drug or drugs or device which
will have usefulness and simplicity. Whenever such a single official name has
not been recommended within one hundred and eighty days after such request, or
the Secretary determines that any name so recommended is not useful for any
reason, he shall designate a single official name for such drug or drugs or
device. Whenever he determines that the name so recommended is useful, he shall
designate that name as the official name of such drug or drugs or device. Such
designation shall be made as a regulation upon public notice and in accordance
with the procedure set forth in section 553 of title 5.
- (d) Revised official names; compilation, publication, and public
distribution of listings
After each such review, and at such other times as the Secretary may
determine to be necessary or desirable, the Secretary shall cause to be
compiled, published, and publicly distributed a list which shall list all
revised official names of drugs or devices designated under this section and
shall contain such descriptive and explanatory matter as the Secretary may
determine to be required for the effective use of those names.
- (e) Request by compiler of official compendium for designation of
name
Upon a request in writing by any compiler of an official compendium that the
Secretary exercise the authority granted to him under subsection (a) of this
section, he shall upon public notice and in accordance with the procedure set
forth in section 553 of title 5 designate the official name of the drug or
device for which the request is made.
§ 359. Nonapplicability of subchapter to cosmetics.
This subchapter, as amended by the Drug Amendments of 1962, shall not apply
to any cosmetic unless such cosmetic is also a drug or device or component
thereof.
§ 360. Registration of producers of drugs or devices.
As used in this section -
- (1) the term ''manufacture, preparation, propagation, compounding, or
processing'' shall include repackaging or otherwise changing the container,
wrapper, or labeling of any drug package or device package in furtherance of the
distribution of the drug or device from the original place of manufacture to the
person who makes final delivery or sale to the ultimate consumer or user; and
- (2) the term ''name'' shall include in the case of a partnership the name
of each partner and, in the case of a corporation, the name of each corporate
officer and director, and the State of incorporation.
On or before December 31 of each year every person who owns or operates any
establishment in any State engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or drugs or a device or devices shall
register with the Secretary his name, places of business, and all such
establishments.
Every person upon first engaging in the manufacture, preparation,
propagation, compounding, or processing of a drug or drugs or a device or
devices in any establishment which he owns or operates in any State shall
immediately register with the Secretary his name, place of business, and such
establishment.
- (d) Additional establishments
Every person duly registered in accordance with the foregoing subsections of
this section shall immediately register with the Secretary any additional
establishment which he owns or operates in any State and in which he begins the
manufacture, preparation, propagation, compounding, or processing of a drug or
drugs or a device or devices.
- (e) Registration number; uniform system for identification of
devices intended for human use
The Secretary may assign a registration number to any person or any
establishment registered in accordance with this section. The Secretary may also
assign a listing number to each drug or class of drugs listed under subsection
(j) of this section. Any number assigned pursuant to the preceding sentence
shall be the same as that assigned pursuant to the National Drug Code. The
Secretary may by regulation prescribe a uniform system for the identification of
devices intended for human use and may require that persons who are required to
list such devices pursuant to subsection (j) of this section shall list such
devices in accordance with such system.
- (f) Availability of registrations for inspection
The Secretary shall make available for inspection, to any person so
requesting, any registration filed pursuant to this section; except that any
list submitted pursuant to paragraph (3) of subsection (j) of this section and
the information accompanying any list or notice filed under paragraph (1) or (2)
of that subsection shall be exempt from such inspection unless the Secretary
finds that such an exemption would be inconsistent with protection of the public
health.
- (g) Exclusions from application of section
The foregoing subsections of this section shall not apply to -
- (1) pharmacies which maintain establishments in conformance with any
applicable local laws regulating the practice of pharmacy and medicine and which
are regularly engaged in dispensing prescription drugs or devices, upon
prescriptions of practitioners licensed to administer such drugs or devices to
patients under the care of such practitioners in the course of their
professional practice, and which do not manufacture, prepare, propagate,
compound, or process drugs or devices for sale other than in the regular course
of their business of dispensing or selling drugs or devices at retail;
- (2) practitioners licensed by law to prescribe or administer drugs or
devices and who manufacture, prepare, propagate, compound, or process drugs or
devices solely for use in the course of their professional practice;
- (3) persons who manufacture, prepare, propagate, compound, or process drugs
or devices solely for use in research, teaching, or chemical analysis and not
for sale;
- (4) such other classes of persons as the Secretary may by regulation exempt
from the application of this section upon a finding that registration by such
classes of persons in accordance with this section is not necessary for the
protection of the public health.
- (h) Inspection of premises
Every establishment in any State registered with the Secretary pursuant to
this section shall be subject to inspection pursuant to section 374 of this
title and every such establishment engaged in the manufacture, propagation,
compounding, or processing of a drug or drugs or of a device or devices
classified in class II or III shall be so inspected by one or more officers or
employees duly designated by the Secretary at least once in the two-year period
beginning with the date of registration of such establishment pursuant to this
section and at least once in every successive two-year period thereafter.
- (i) Foreign establishments
Any establishment within any foreign country engaged in the manufacture,
preparation, propagation, compounding, or processing of a drug or drugs, or a
device or devices, shall be permitted to register under this section pursuant to
regulations promulgated by the Secretary. Such regulations shall require such
establishment to provide the information required by subsection (j) of this
section and shall require such establishment to provide the information required
by subsection (j) of this section in the case of a device or devices and shall
include provisions for registration of any such establishment upon condition
that adequate and effective means are available, by arrangement with the
government of such foreign country or otherwise, to enable the Secretary to
determine from time to time whether drugs or devices manufactured, prepared,
propagated, compounded, or processed in such establishment, if imported or
offered for import into the United States, shall be refused admission on any of
the grounds set forth in section 381(a) of this title.
- (j) Filing of lists of drugs and devices manufactured, prepared,
propagated and compounded by registrants; statements; accompanying disclosures
- (1) Every person who registers with the Secretary under subsection (b),
(c), or (d) of this section shall, at the time of registration under any such
subsection, file with the Secretary a list of all drugs and a list of all
devices and a brief statement of the basis for believing that each device
included in the list is a device rather than a drug (with each drug and device
in each list listed by its established name (as defined in section 352(e) of
this title) and by any proprietary name) which are being manufactured, prepared,
propagated, compounded, or processed by him for commercial distribution and
which he has not included in any list of drugs or devices filed by him with the
Secretary under this paragraph or paragraph (2) before such time of
registration. Such list shall be prepared in such form and manner as the
Secretary may prescribe and shall be accompanied by -
- (A) in the case of a drug contained in the applicable list and subject to
sections 355, 356, 357, or 360b of this title, or a device intended for human
use contained in the applicable list with respect to which a performance
standard has been established under section 360d of this title or which is
subject to section 360e of this title, a reference to the authority for the
marketing of such drug or device and a copy of all labeling for such drug or
device;
- (B) in the case of any other drug or device contained in an applicable list
-
- (i) which drug is subject to section 353(b)(1) of this title, or which
device is a restricted device, a copy of all labeling for such drug or device, a
representative sampling of advertisements for such drug or device, and, upon
request made by the Secretary for good cause, a copy of all advertisements for a
particular drug product or device, or
- (ii) which drug is not subject to section 353(b)(1) of this title or which
device is not a restricted device, the label and package insert for such drug or
device and a representative sampling of any other labeling for such drug or
device;
- (C) in the case of any drug contained in an applicable list which is
described in subparagraph (B), a quantitative listing of its active ingredient
or ingredients, except that with respect to a particular drug product the
Secretary may require the submission of a quantitative listing of all
ingredients if he finds that such submission is necessary to carry out the
purposes of this chapter; and
- (D) if the registrant filing a list has determined that a particular drug
product or device contained in such list is not subject to section 355, 356,
357, or 360b of this title, or the particular device contained in such list is
not subject to a performance standard established under section 360d of this
title or to section 360e of this title or is not a restricted device a brief
statement of the basis upon which the registrant made such determination if the
Secretary requests such a statement with respect to that particular drug product
or device.
- (2) Each person who registers with the Secretary under this section shall
report to the Secretary once during the month of June of each year and once
during the month of December of each year the following information:
- (A) A list of each drug or device introduced by the registrant for
commercial distribution which has not been included in any list previously filed
by him with the Secretary under this subparagraph or paragraph (1) of this
subsection. A list under this subparagraph shall list a drug or device by its
established name (as defined in section 352(e) of this title), and by any
proprietary name it may have and shall be accompanied by the other information
required by paragraph (1).
- (B) If since the date the registrant last made a report under this
paragraph (or if he has not made a report under this paragraph, since February
1, 1973) he has discontinued the manufacture, preparation, propagation,
compounding, or processing for commercial distribution of a drug or device
included in a list filed by him under subparagraph (A) or paragraph (1); notice
of such discontinuance, the date of such discontinuance, and the identity (by
established name (as defined in section 352(e) of this title) and by any
proprietary name) of such drug or device.
- (C) If since the date the registrant reported pursuant to subparagraph (B)
a notice of discontinuance he has resumed the manufacture, preparation,
propagation, compounding, or processing for commercial distribution of the drug
or device with respect to which such notice of discontinuance was reported;
notice of such resumption, the date of such resumption, the identity of such
drug or device (each by established name (as defined in section 352(e) of this
title) and by any proprietary name), and the other information required by
paragraph (1), unless the registrant has previously reported such resumption to
the Secretary pursuant to this subparagraph.
- (D) Any material change in any information previously submitted pursuant to
this paragraph or paragraph (1).
- (3) The Secretary may also require each registrant under this section to
submit a list of each drug product which (A) the registrant is manufacturing,
preparing, propagating, compounding, or processing for commercial distribution,
and (B) contains a particular ingredient. The Secretary may not require the
submission of such a list unless he has made a finding that the submission of
such a list is necessary to carry out the purposes of this chapter.
- (k) Report preceding introduction of devices into interstate
commerce
Each person who is required to register under this section and who proposes
to begin the introduction or delivery for introduction into interstate commerce
for commercial distribution of a device intended for human use shall, at least
ninety days before making such introduction or delivery, report to the Secretary
(in such form and manner as the Secretary shall by regulation prescribe) -
- (1) the class in which the device is classified under section 360c of
this title or if such person determines that the device is not classified under
such section, a statement of that determination and the basis for such person's
determination that the device is or is not so classified, and
- (2) action taken by such person to comply with requirements under section
360d or 360e of this title which are applicable to the device.
§ 360a. Repealed.
§ 360a. Repealed. Pub. L. 91-513, title II, Sec. 701(a), Oct. 27, 1970,
84 Stat. 1281
§ 360b. New animal drugs.
- (a) Unsafe new animal drugs and animal feed containing such drugs;
conditions of safety; exemption of drugs for research
- (1) A new animal drug shall, with respect to any particular use or intended
use of such drug, be deemed unsafe for the purposes of section 351(a)(5) and
section 342(a)(2)(D) of this title unless -
- (A) there is in effect an approval of an application filed pursuant to
subsection (b) of this section with respect to such use or intended use of such
drug, and
- (B) such drug, its labeling, and such use conform to such approved
application. A new animal drug shall also be deemed unsafe for such purposes in
the event of removal from the establishment of a manufacturer, packer, or
distributor of such drug for use in the manufacture of animal feed in any State
unless at the time of such removal such manufacturer, packer, or distributor has
an unrevoked written statement from the consignee of such drug, or notice from
the Secretary, to the effect that, with respect to the use of such drug in
animal feed, such consignee -
- (i) is the holder of an approved application under subsection (m) of this
section; or
- (ii) will, if the consignee is not a user of the drug, ship such drug only
to a holder of an approved application under subsection (m) of this section.
- (2) An animal feed bearing or containing a new animal drug shall, with
respect to any particular use or intended use of such animal feed, be deemed
unsafe for the purposes of section 351(a)(6) of this title unless -
- (A) there is in effect an approval of an application filed pursuant to
subsection (b) of this section with respect to such drugs, as used in such
animal feed,
- (B) there is in effect an approval of an application pursuant to subsection
(m)(1) of this section with respect to such animal feed, and
- (C) such animal feed, its labeling, and such use conform to the conditions
and indications of use published pursuant to subsection (i) of this section and
to the application with respect thereto approved under subsection (m) of this
section.
- (3) A new animal drug or an animal feed bearing or containing a new animal
drug shall not be deemed unsafe for the purposes of section 351(a)(5) or (6) of
this title if such article is for investigational use and conforms to the terms
of an exemption in effect with respect thereto under subsection (j) of this
section.
- (4)
- (A) Except as provided in subparagraph (B), if an approval of an
application filed under subsection (b) of this section is in effect with respect
to a particular use or intended use of a new animal drug, the drug shall not be
deemed unsafe for the purposes of paragraph (1) and shall be exempt from the
requirements of section 352(f) of this title with respect to a different use or
intended use of the drug, other than a use in or on animal feed, if such use or
intended use -
- (i) is by or on the lawful written or oral order of a licensed veterinarian
within the context of a veterinarian-client-patient relationship, as defined by
the Secretary; and •(ii) is in compliance with regulations promulgated by
the Secretary that establish the conditions for such different use or intended
use. The regulations promulgated by the Secretary under clause
- (ii) may prohibit particular uses of an animal drug and shall not permit
such different use of an animal drug if the labeling of another animal drug that
contains the same active ingredient and which is in the same dosage form and
concentration provides for such different use.
- (B) If the Secretary finds that there is a reasonable probability that a
use of an animal drug authorized under subparagraph (A) may present a risk to
the public health, the Secretary may -
- (i) establish a safe level for a residue of an animal drug when it is used
for such different use authorized by subparagraph (A); and
- (ii) require the development of a practical, analytical method for the
detection of residues of such drug above the safe level established under clause
(i). The use of an animal drug that results in residues exceeding a safe level
established under clause (i) shall be considered an unsafe use of such drug
under paragraph (1). Safe levels may be established under clause (i) either by
regulation or order.
- (C) The Secretary may by general regulation provide access to the records
of veterinarians to ascertain any use or intended use authorized under
subparagraph (A) that the Secretary has determined may present a risk to the
public health.
- (D) If the Secretary finds, after affording an opportunity for public
comment, that a use of an animal drug authorized under subparagraph (A) presents
a risk to the public health or that an analytical method required under
subparagraph (B) has not been developed and submitted to the Secretary, the
Secretary may, by order, prohibit any such use.
- (5) If the approval of an application filed under section 355 of this title
is in effect, the drug under such application shall not be deemed unsafe for
purposes of paragraph (1) and shall be exempt from the requirements of section
352(f) of this title with respect to a use or intended use of the drug in
animals if such use or intended use -
- (A) is by or on the lawful written or oral order of a licensed veterinarian
within the context of a veterinarian-client-patient relationship, as defined by
the Secretary; and
- (B) is in compliance with regulations promulgated by the Secretary that
establish the conditions for the use or intended use of the drug in animals.
- (b) Filing application for uses of new animal drug; contents;
patent information; abbreviated application
- (1) Any person may file with the Secretary an application with respect to
any intended use or uses of a new animal drug. Such person shall submit to the
Secretary as a part of the application
- (A) full reports of investigations which have been made to show whether or
not such drug is safe and effective for use;
- (B) a full list of the articles used as components of such drug;
- (C) a full statement of the composition of such drug;
- (D) a full description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing of such drug;
- (E) such samples of such drug and of the articles used as components
thereof, of any animal feed for use in or on which such drug is intended, and of
the edible portions or products (before or after slaughter) of animals to which
such drug (directly or in or on animal feed) is intended to be administered, as
the Secretary may require;
- (F) specimens of the labeling proposed to be used for such drug, or in case
such drug is intended for use in animal feed, proposed labeling appropriate for
such use, and specimens of the labeling for the drug to be manufactured, packed,
or distributed by the applicant;
- (G) a description of practicable methods for determining the quantity, if
any, of such drug in or on food, and any substance formed in or on food, because
of its use; and
- (H) the proposed tolerance or withdrawal period or other use restrictions
for such drug if any tolerance or withdrawal period or other use restrictions
are required in order to assure that the proposed use of such drug will be safe.
The
applicant shall file with the application the patent number and the expiration
date of any patent which claims the new animal drug for which the applicant
filed the application or which claims a method of using such drug and with
respect to which a claim of patent infringement could reasonably be asserted if
a person not licensed by the owner engaged in the manufacture, use, or sale of
the drug. If an application is filed under this subsection for a drug and a
patent which claims such drug or a method of using such drug is issued after the
filing date but before approval of the application, the applicant shall amend
the application to include the information required by the preceding sentence.
Upon approval of the application, the Secretary shall publish information
submitted under the two preceding sentences.
- (2) Any person may file with the Secretary an abbreviated application for
the approval of a new animal drug. An abbreviated application shall contain the
information required by subsection (n) of this section.
- (c) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order; abbreviated applications;
withdrawal periods; effective date of approval; relationship to other
applications; withdrawal or suspension of approval; bioequivalence; filing of
additional patent information
- (1) Within one hundred and eighty days after the filing of an application
pursuant to subsection (b) of this section, or such additional period as may be
agreed upon by the Secretary and the applicant, the Secretary shall either
- (A) issue an order approving the application if he then finds that none of
the grounds for denying approval specified in subsection (d) of this section
applies, or
- (B) give the applicant notice of an opportunity for a hearing before the
Secretary under subsection (d) of this section on the question whether such
application is approvable. If the applicant elects to accept the opportunity for
a hearing by written request within thirty days after such notice, such hearing
shall commence not more than ninety days after the expiration of such thirty
days unless the Secretary and the applicant otherwise agree. Any such hearing
shall thereafter be conducted on an expedited basis and the Secretary's order
thereon shall be issued within ninety days after the date fixed by the Secretary
for filing final briefs.
- (2)
- (A) Subject to subparagraph (C), the Secretary shall approve an abbreviated
application for a drug unless the Secretary finds -
- (i) the methods used in, or the facilities and controls used for, the
manufacture, processing, and packing of the drug are inadequate to assure and
preserve its identity, strength, quality, and purity;
- (ii) the conditions of use prescribed, recommended, or suggested in the
proposed labeling are not reasonably certain to be followed in practice or,
except as provided in subparagraph (B), information submitted with the
application is insufficient to show that each of the proposed conditions of use
or similar limitations (whether in the labeling or published pursuant to
subsection (i) of this section) have been previously approved for the approved
new animal drug referred to in the application;
- (iii) information submitted with the application is insufficient to show
that the active ingredients are the same as those of the approved new animal
drug referred to in the application;
- (iv)
- (I) if the application is for a drug whose active ingredients, route of
administration, dosage form, strength, or use with other animal drugs in animal
feed is the same as the active ingredients, route of administration, dosage
form, strength, or use with other animal drugs in animal feed of the approved
new animal drug referred to in the application, information submitted in the
application is insufficient to show that the active ingredients, route of
administration, dosage form, strength, or use with other animal drugs in animal
feed is the same as that of the approved new animal drug, or
- (II) if the application is for a drug whose active ingredients, route of
administration, dosage form, strength, or use with other animal drugs in animal
feed is different from that of the approved new animal drug referred to in the
application, no petition to file an application for the drug with the different
active ingredients, route of administration, dosage form, strength, or use with
other animal drugs in animal feed was approved under subsection (n)(3) of this
section;
- (v) if the application was filed pursuant to the approval of a petition
under subsection (n)(3) of this section, the application did not contain the
information required by the Secretary respecting the active ingredients, route
of administration, dosage form, strength, or use with other animal drugs in
animal feed which is not the same;
- (vi) information submitted in the application is insufficient to show that
the drug is bioequivalent to the approved new animal drug referred to in the
application, or if the application is filed under a petition approved pursuant
to subsection (n)(3) of this section, information submitted in the application
is insufficient to show that the active ingredients of the new animal drug are
of the same pharmacological or therapeutic class as the pharmacological or
therapeutic class of the approved new animal drug and that the new animal drug
can be expected to have the same therapeutic effect as the approved new animal
drug when used in accordance with the labeling;
- (vii) information submitted in the application is insufficient to show that
the labeling proposed for the drug is the same as the labeling approved for the
approved new animal drug referred to in the application except for changes
required because of differences approved under a petition filed under subsection
(n)(3) of this section, because of a different withdrawal period, or because the
drug and the approved new animal drug are produced or distributed by different
manufacturers;
- (viii) information submitted in the application or any other information
available to the Secretary shows that (I) the inactive ingredients of the drug
are unsafe for use under the conditions prescribed, recommended, or suggested in
the labeling proposed for the drug, (II) the composition of the drug is unsafe
under such conditions because of the type or quantity of inactive ingredients
included or the manner in which the inactive ingredients are included, or (III)
in the case of a drug for food producing animals, the inactive ingredients of
the drug or its composition may be unsafe with respect to human food safety;
- (ix) the approval under subsection (b)(1) of this section of the approved
new animal drug referred to in the application filed under subsection (b)(2) of
this section has been withdrawn or suspended for grounds described in paragraph
(1) of subsection (e) of this section, the Secretary has published a notice of a
hearing to withdraw approval of the approved new animal drug for such grounds,
the approval under this paragraph of the new animal drug for which the
application under subsection (b)(2) of this section was filed has been withdrawn
or suspended under subparagraph (G) for such grounds, or the Secretary has
determined that the approved new animal drug has been withdrawn from sale for
safety or effectiveness reasons;
- (x) the application does not meet any other requirement of subsection (n)
of this section; or
- (xi) the application contains an untrue statement of material fact.
- (B) If the Secretary finds that a new animal drug for which an application
is submitted under subsection (b)(2) of this section is bioequivalent to the
approved new animal drug referred to in such application and that residues of
the new animal drug are consistent with the tolerances established for such
approved new animal drug but at a withdrawal period which is different than the
withdrawal period approved for such approved new animal drug, the Secretary may
establish, on the basis of information submitted, such different withdrawal
period as the withdrawal period for the new animal drug for purposes of the
approval of such application for such drug.
- (C) Within 180 days of the initial receipt of an application under
subsection (b)(2) of this section or within such additional period as may be
agreed upon by the Secretary and the applicant, the Secretary shall approve or
disapprove the application.
- (D) The approval of an application filed under subsection (b)(2) of this
section shall be made effective on the last applicable date determined under the
following:
- (i) If the applicant only made a certification described in clause (i) or
(ii) of subsection (n)(1)(G) of this section or in both such clauses, the
approval may be made effective immediately.
- (ii) If the applicant made a certification described in clause (iii) of
subsection (n)(1)(G) of this section, the approval may be made effective on the
date certified under clause (iii).
- (iii) If the applicant made a certification described in clause (iv) of
subsection (n)(1)(G) of this section, the approval shall be made effective
immediately unless an action is brought for infringement of a patent which is
the subject of the certification before the expiration of 45 days from the date
the notice provided under subsection (n)(2)(B)(i) of this section is received.
If such an action is brought before the expiration of such days, the approval
shall be made effective upon the expiration of the 30 month period beginning on
the date of the receipt of the notice provided under subsection (n)(2)(B) of
this section or such shorter or longer period as the court may order because
either party to the action failed to reasonably cooperate in expediting the
action, except that if before the expiration of such period -
- (I) the court decides that such patent is invalid or not infringed, the
approval shall be made effective on the date of the court decision,
- (II) the court decides that such patent has been infringed, the approval
shall be made effective on such date as the court orders under section
271(e)(4)(A) of title 35, or
- (III) the court grants a preliminary injunction prohibiting the applicant
from engaging in the commercial manufacture or sale of the drug until the court
decides the issues of patent validity and infringement and if the court decides
that such patent is invalid or not infringed, the approval shall be made
effective on the date of such court decision.
In such an
action, each of the parties shall reasonably cooperate in expediting the action.
Until the expiration of 45 days from the date the notice made under subsection
(n)(2)(B) of this section is received, no action may be brought under section
2201 of title 28 for a declaratory judgment with respect to the patent. Any
action brought under section 2201 of title 28 shall be brought in the judicial
district where the defendant has its principal place of business or a regular
and established place of business.
- (iv) If the application contains a certification described in clause (iv)
of subsection (n)(1)(G) of this section and is for a drug for which a previous
application has been filed under this subsection containing such a
certification, the application shall be made effective not earlier than 180 days
after -
- (I) the date the Secretary receives notice from the applicant under the
previous application of the first commercial marketing of the drug under the
previous application, or
- (II) the date of a decision of a court in an action described in subclause
(III) (FOOTNOTE 1) holding the patent which is the subject of the certification
to be invalid or not infringed, (FOOTNOTE 1) So in original. Probably should
be ''clause (iii)(III)''.
- whichever is earlier.
- (E) If the Secretary decides to disapprove an application, the Secretary
shall give the applicant notice of an opportunity for a hearing before the
Secretary on the question of whether such application is approvable. If the
applicant elects to accept the opportunity for hearing by written request within
30 days after such notice, such hearing shall commence not more than 90 days
after the expiration of such 30 days unless the Secretary and the applicant
otherwise agree. Any such hearing shall thereafter be conducted on an expedited
basis and the Secretary's order thereon shall be issued within 90 days after the
date fixed by the Secretary for filing final briefs.
- (F)
- (i) If an application submitted under subsection (b)(1) of this section for
a drug, no active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application under subsection
(b)(1) of this section, is approved after November 16, 1988, no application may
be submitted under subsection (b)(2) of this section which refers to the drug
for which the subsection (b)(1) application was submitted before the expiration
of 5 years from the date of the approval of the application under subsection
(b)(1) of this section, except that such an application may be submitted under
subsection (b)(2) of this section after the expiration of 4 years from the date
of the approval of the subsection (b)(1) application if it contains a
certification of patent invalidity or noninfringement described in clause (iv)
of subsection (n)(1)(G) of this section. The approval of such an application
shall be made effective in accordance with subparagraph (B) except that, if an
action for patent infringement is commenced during the one-year period beginning
48 months after the date of the approval of the subsection (b) application, the
30 month period referred to in subparagraph (D)(iii) shall be extended by such
amount of time (if any) which is required for seven and one-half years to have
elapsed from the date of approval of the subsection (b) application.
- (ii) If an application submitted under subsection (b)(1) of this section
for a drug, which includes an active ingredient (including any ester or salt of
the active ingredient) that has been approved in another application approved
under such subsection, is approved after November 16, 1988, and if such
application contains reports of new clinical or field investigations (other than
bioequivalence or residue studies) and, in the case of food producing animals,
human food safety studies (other than bioequivalence or residue studies)
essential to the approval of the application and conducted or sponsored by the
applicant, the Secretary may not make the approval of an application submitted
under subsection (b)(2) of this section for the conditions of approval of such
drug in the subsection (b)(1) application effective before the expiration of 3
years from the date of the approval of the application under subsection (b)(1)
of this section for such drug.
- (iii) If a supplement to an application approved under subsection (b)(1) of
this section is approved after November 16, 1988, and the supplement contains
reports of new clinical or field investigations (other than bioequivalence or
residue studies) and, in the case of food producing animals, human food safety
studies (other than bioequivalence or residue studies) essential to the approval
of the supplement and conducted or sponsored by the person submitting the
supplement, the Secretary may not make the approval of an application submitted
under subsection (b)(2) of this section for a change approved in the supplement
effective before the expiration of 3 years from the date of the approval of the
supplement.
- (iv) An applicant under subsection (b)(1) of this section who comes within
the provisions of clause (i) of this subparagraph as a result of an application
which seeks approval for a use solely in non-food producing animals, may elect,
within 10 days of receiving such approval, to waive clause (i) of this
subparagraph, in which event the limitation on approval of applications
submitted under subsection (b)(2) of this section set forth in clause (ii) of
this subparagraph shall be applicable to the subsection (b)(1) application.
- (v) If an application (including any supplement to a new animal drug
application) submitted under subsection (b)(1) of this section for a new animal
drug for a food-producing animal use, which includes an active ingredient
(including any ester or salt of the active ingredient) which has been the
subject of a waiver under subparagraph (B)(iv) is approved after November 16,
1988, and if the application contains reports of clinical or field
investigations or human food safety studies (other than bioequivalence or
residue studies) essential to the new approval of the application and conducted
or sponsored by the applicant, the Secretary may not make the approval of an
application (including any supplement to such application) submitted under
subsection (b)(2) of this section for the new conditions of approval of such
drug in the subsection (b)(1) application effective before the expiration of
five years from the date of approval of the application under subsection (b)(1)
of this section for such drug. The provisions of this paragraph shall apply only
to the first approval for a food-producing animal use for the same applicant
after the waiver under subparagraph (B)(iv).
- (G) If an approved application submitted under subsection (b)(2) of this
section for a new animal drug refers to a drug the approval of which was
withdrawn or suspended for grounds described in paragraph (1) or (2) of
subsection (e) of this section or was withdrawn or suspended under this
subparagraph or which, as determined by the Secretary, has been withdrawn from
sale for safety or effectiveness reasons, the approval of the drug under this
paragraph shall be withdrawn or suspended -
- (i) for the same period as the withdrawal or suspension under subsection
(e) of this section or this subparagraph, or
- (ii) if the approved new animal drug has been withdrawn from sale, for the
period of withdrawal from sale or, if earlier, the period ending on the date the
Secretary determines that the withdrawal from sale is not for safety or
effectiveness reasons.
- (H) For purposes of this paragraph:
- (i) The term ''bioequivalence'' means the rate and extent to which the
active ingredient or therapeutic ingredient is absorbed from a new animal drug
and becomes available at the site of drug action.
- (ii) A new animal drug shall be considered to be bioequivalent to the
approved new animal drug referred to in its application under subsection (n) of
this section if -
- (I) the rate and extent of absorption of the drug do not show a significant
difference from the rate and extent of absorption of the approved new animal
drug referred to in the application when administered at the same dose of the
active ingredient under similar experimental conditions in either a single dose
or multiple doses;
- (II) the extent of absorption of the drug does not show a significant
difference from the extent of absorption of the approved new animal drug
referred to in the application when administered at the same dose of the active
ingredient under similar experimental conditions in either a single dose or
multiple doses and the difference from the approved new animal drug in the rate
of absorption of the drug is intentional, is reflected in its proposed labeling,
is not essential to the attainment of effective drug concentrations in use, and
is considered scientifically insignificant for the drug in attaining the
intended purposes of its use and preserving human food safety; or
- (III) in any case in which the Secretary determines that the measurement of
the rate and extent of absorption or excretion of the new animal drug in
biological fluids is inappropriate or impractical, an appropriate acute
pharmacological effects test or other test of the new animal drug and, when
deemed scientifically necessary, of the approved new animal drug referred to in
the application in the species to be tested or in an appropriate animal model
does not show a significant difference between the new animal drug and such
approved new animal drug when administered at the same dose under similar
experimental conditions.
If the approved new animal drug referred
to in the application for a new animal drug under subsection (n) of this section
is approved for use in more than one animal species, the bioequivalency
information described in subclauses (I), (II), and (III) shall be obtained for
one species, or if the Secretary deems appropriate based on scientific
principles, shall be obtained for more than one species. The Secretary may
prescribe the dose to be used in determining bioequivalency under subclause (I),
(II), or (III). To assure that the residues of the new animal drug will be
consistent with the established tolerances for the approved new animal drug
referred to in the application under subsection (b)(2) of this section upon the
expiration of the withdrawal period contained in the application for the new
animal drug, the Secretary shall require bioequivalency data or residue
depletion studies of the new animal drug or such other data or studies as the
Secretary considers appropriate based on scientific principles. If the Secretary
requires one or more residue studies under the preceding sentence, the Secretary
may not require that the assay methodology used to determine the withdrawal
period of the new animal drug be more rigorous than the methodology used to
determine the withdrawal period for the approved new animal drug referred to in
the application. If such studies are required and if the approved new animal
drug, referred to in the application for the new animal drug for which such
studies are required, is approved for use in more than one animal species, such
studies shall be conducted for one species, or if the Secretary deems
appropriate based on scientific principles, shall be conducted for more than one
species.
- (3) If the patent information described in subsection (b)(1) of this
section could not be filed with the submission of an application under
subsection (b)(1) of this section because the application was filed before the
patent information was required under subsection (b)(1) of this section or a
patent was issued after the application was approved under such subsection, the
holder of an approved application shall file with the Secretary the patent
number and the expiration date of any patent which claims the new animal drug
for which the application was filed or which claims a method of using such drug
and with respect to which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner engaged in the manufacture, use,
or sale of the drug. If the holder of an approved application could not file
patent information under subsection (b)(1) of this section because it was not
required at the time the application was approved, the holder shall file such
information under this subsection not later than 30 days after November 16,
1988, and if the holder of an approved application could not file patent
information under subsection (b)(1) of this section because no patent had been
issued when an application was filed or approved, the holder shall file such
information under this subsection not later than 30 days after the date the
patent involved is issued. Upon the submission of patent information under this
subsection, the Secretary shall publish it.
- (d) Grounds for refusing application; approval of application;
factors; ''substantial evidence'' defined
- (1) If the Secretary finds, after due notice to the applicant in accordance
with subsection (c) of this section and giving him an opportunity for a hearing,
in accordance with said subsection, that -
- (A) the investigations, reports of which are required to be submitted to
the Secretary pursuant to subsection (b) of this section, do not include
adequate tests by all methods reasonably applicable to show whether or not such
drug is safe for use under the conditions prescribed, recommended, or suggested
in the proposed labeling thereof;
- (B) the results of such tests show that such drug is unsafe for use under
such conditions or do not show that such drug is safe for use under such
conditions;
- (C) the methods used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug are inadequate to preserve its
identity, strength, quality, and purity;
- (D) upon the basis of the information submitted to him as part of the
application, or upon the basis of any other information before him with respect
to such drug, he has insufficient information to determine whether such drug is
safe for use under such conditions;
- (E) evaluated on the basis of the information submitted to him as part of
the application and any other information before him with respect to such drug,
there is a lack of substantial evidence that the drug will have the effect it
purports or is represented to have under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof;
- (F) upon the basis of the information submitted to him as part of the
application or any other information before him with respect to such drug, the
tolerance limitation proposed, if any, exceeds that reasonably required to
accomplish the physical or other technical effect for which the drug is
intended;
- (G) the application failed to contain the patent information prescribed by
subsection (b)(1) of this section;
- (H) based on a fair evaluation of all material facts, such labeling is
false or misleading in any particular; or
- (I) such drug induces cancer when ingested by man or animal or, after tests
which are appropriate for the evaluation of the safety of such drug, induces
cancer in man or animal, except that the foregoing provisions of this
subparagraph shall not apply with respect to such drug if the Secretary finds
that, under the conditions of use specified in proposed labeling and reasonably
certain to be followed in practice (i) such drug will not adversely affect the
animals for which it is intended, and (ii) no residue of such drug will be found
(by methods of examination prescribed or approved by the Secretary by
regulations, which regulations shall not be subject to subsections (c), (d), and
(h) of this section), in any edible portion of such animals after slaughter or
in any food yielded by or derived from the living animals;
he
shall issue an order refusing to approve the application. If, after such notice
and opportunity for hearings, the Secretary finds that subparagraphs (A) through
(I) do not apply, he shall issue an order approving the application.
- (2) In determining whether such drug is safe for use under the conditions
prescribed, recommended, or suggested in the proposed labeling thereof, the
Secretary shall consider, among other relevant factors, (A) the probable
consumption of such drug and of any substance formed in or on food because of
the use of such drug, (B) the cumulative effect on man or animal of such drug,
taking into account any chemically or pharmacologically related substance, (C)
safety factors which in the opinion of experts, qualified by scientific training
and experience to evaluate the safety of such drugs, are appropriate for the use
of animal experimentation data, and (D) whether the conditions of use
prescribed, recommended, or suggested in the proposed labeling are reasonably
certain to be followed in practice. Any order issued under this subsection
refusing to approve an application shall state the findings upon which it is
based.
- (3) As used in this subsection and subsection (e) of this section, the term
''substantial evidence'' means evidence consisting of adequate and
well-controlled investigations, including field investigation, by experts
qualified by scientific training and experience to evaluate the effectiveness of
the drug involved, on the basis of which it could fairly and reasonably be
concluded by such experts that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof.
- (e) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to health of man or animals
- (1) The Secretary shall, after due notice and opportunity for hearing to
the applicant, issue an order withdrawing approval of an application filed
pursuant to subsection (b) of this section with respect to any new animal drug
if the Secretary finds -
- (A) that experience or scientific data show that such drug is unsafe for
use under the conditions of use upon the basis of which the application was
approved or the condition of use authorized under subsection (a)(4)(A) of this
section;
- (B) that new evidence not contained in such application or not available to
the Secretary until after such application was approved, or tests by new
methods, or tests by methods not deemed reasonably applicable when such
application was approved, evaluated together with the evidence available to the
Secretary when the application was approved, shows that such drug is not shown
to be safe for use under the conditions of use upon the basis of which the
application was approved or that subparagraph (I) of paragraph (1) of subsection
(d) of this section applies to such drug;
- (C) on the basis of new information before him with respect to such drug,
evaluated together with the evidence available to him when the application was
approved, that there is a lack of substantial evidence that such drug will have
the effect it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling thereof;
- (D) the patent information prescribed by subsection (c)(3) of this section
was not filed within 30 days after the receipt of written notice from the
Secretary specifying the failure to file such information;
- (E) that the application contains any untrue statement of a material fact;
or
- (F) that the applicant has made any changes from the standpoint of safety
or effectiveness beyond the variations provided for in the application unless he
has supplemented the application by filing with the Secretary adequate
information respecting all such changes and unless there is in effect an
approval of the supplemental application. The supplemental application shall be
treated in the same manner as the original application.
If the
Secretary (or in his absence the officer acting as Secretary) finds that there
is an imminent hazard to the health of man or of the animals for which such drug
is intended, he may suspend the approval of such application immediately, and
give the applicant prompt notice of his action and afford the applicant the
opportunity for an expedited hearing under this subsection; but the authority
conferred by this sentence to suspend the approval of an application shall not
be delegated.
- (2) The Secretary may also, after due notice and opportunity for hearing to
the applicant, issue an order withdrawing the approval of an application with
respect to any new animal drug under this section if the Secretary finds -
- (A) that the applicant has failed to establish a system for maintaining
required records, or has repeatedly or deliberately failed to maintain such
records or to make required reports in accordance with a regulation or order
under subsection (1) of this section, or the applicant has refused to permit
access to, or copying or verification of, such records as required by paragraph
(2) of such subsection;
- (B) that on the basis of new information before him, evaluated together
with the evidence before him when the application was approved, the methods used
in, or the facilities and controls used for, the manufacture, processing, and
packing of such drug are inadequate to assure and preserve its identity,
strength, quality, and purity and were not made adequate within a reasonable
time after receipt of written notice from the Secretary specifying the matter
complained of; or
- (C) that on the basis of new information before him, evaluated together
with the evidence before him when the application was approved, the labeling of
such drug, based on a fair evaluation of all material facts, is false or
misleading in any particular and was not corrected within a reasonable time
after receipt of written notice from the Secretary specifying the matter
complained of.
- (3) Any order under this subsection shall state the findings upon which it
is based.
- (f) Revocation of order refusing, withdrawing or suspending
approval of application
Whenever the Secretary finds that the facts so require, he shall revoke any
previous order under subsection (d), (e), or (m) of this section refusing,
withdrawing, or suspending approval of an application and shall approve such
application or reinstate such approval, as may be appropriate.
Orders of the Secretary issued under this section (other than orders
issuing, amending, or repealing regulations) shall be served
- (1) in person by any officer or employee of the department designated
by the Secretary or
- (2) by mailing the order by registered mail or by certified mail addressed
to the applicant or respondent at his last known address in the records of the
Secretary.
An appeal may be taken by the applicant from an order of the Secretary
refusing or withdrawing approval of an application filed under subsection (b) or
(m) of this section. The provisions of subsection (h) of section 355 of this
title shall govern any such appeal.
- (i) Publication in Federal Register; effective date and revocation
or suspension of regulation
When a new animal drug application filed pursuant to subsection (b) of this
section is approved, the Secretary shall by notice, which upon publication shall
be effective as a regulation, publish in the Federal Register the name and
address of the applicant and the conditions and indications of use of the new
animal drug covered by such application, including any tolerance and withdrawal
period or other use restrictions and, if such new animal drug is intended for
use in animal feed, appropriate purposes and conditions of use (including
special labeling requirements) applicable to any animal feed for use in which
such drug is approved, and such other information, upon the basis of which such
application was approved, as the Secretary deems necessary to assure the safe
and effective use of such drug. Upon withdrawal of approval of such new animal
drug application or upon its suspension, the Secretary shall forthwith revoke or
suspend, as the case may be, the regulation published pursuant to this
subsection (i) insofar as it is based on the approval of such application.
- (j) Exemption of drugs for research; discretionary and mandatory
conditions
To the extent consistent with the public health, the Secretary shall
promulgate regulations for exempting from the operation of this section new
animal drugs, and animal feeds bearing or containing new animal drugs, intended
solely for investigational use by experts qualified by scientific training and
experience to investigate the safety and effectiveness of animal drugs. Such
regulations may, in the discretion of the Secretary, among other conditions
relating to the protection of the public health, provide for conditioning such
exemption upon the establishment and maintenance of such records, and the making
of such reports to the Secretary, by the manufacturer or the sponsor of the
investigation of such article, of data (including but not limited to analytical
reports by investigators) obtained as a result of such investigational use of
such article, as the Secretary finds will enable him to evaluate the safety and
effectiveness of such article in the event of the filing of an application
pursuant to this section. Such regulations, among other things, shall set forth
the conditions (if any) upon which animals treated with such articles, and any
products of such animals (before or after slaughter), may be marketed for food
use.
- (k) Food containing new animal drug considered unadulterated while
approval of application for such drug is effective
While approval of an application for a new animal drug is effective, a food
shall not, by reason of bearing or containing such drug or any substance formed
in or on the food because of its use in accordance with such application
(including the conditions and indications of use prescribed pursuant to
subsection (i) of this section), be considered adulterated within the meaning of
clause (1) of section 342(a) of this title.
- (l) Records and reports; required information; regulations and
orders; examination of data; access to records
- (1) In the case of any new animal drug for which an approval of an
application filed pursuant to subsection (b) of this section is in effect, the
applicant shall establish and maintain such records, and make such reports to
the Secretary, of data relating to experience, including experience with uses
authorized under subsection (a)(4)(A) of this section, and other data or
information, received or otherwise obtained by such applicant with respect to
such drug, or with respect to animal feeds bearing or containing such drug, as
the Secretary may by general regulation, or by order with respect to such
application, prescribe on the basis of a finding that such records and reports
are necessary in order to enable the Secretary to determine, or facilitate a
determination, whether there is or may be ground for invoking subsection (e) or
subsection (m)(4) of this section. Such regulation or order shall provide, where
the Secretary deems it to be appropriate, for the examination, upon request, by
the persons to whom such regulation or order is applicable, of similar
information received or otherwise obtained by the Secretary.
- (2) Every person required under this subsection to maintain records, and
every person in charge or custody thereof, shall, upon request of an officer or
employee designated by the Secretary, permit such officer or employee at all
reasonable times to have access to and copy and verify such records.
- (m)
- (1) Filing application for uses of animal feed containing new animal
drug; contents
Any person may file with the Secretary an application
with respect to any intended use or uses of an animal feed bearing or containing
a new animal drug. Such person shall submit to the Secretary as part of the
application (A) a full statement of the composition of such animal feed, (B) an
identification of the regulation or regulations (relating to the new animal drug
or drugs to be used in such feed), published pursuant to subsection (i) of this
section, on which he relies as a basis for approval of his application with
respect to the use of such drug in such feed, (C) a full description of the
methods used in, and the facilities and controls used for, the manufacture,
processing, and packing of such animal feed, (D) specimens of the labeling
proposed to be used for such animal feed, and (E) if so requested by the
Secretary, samples of such animal feed or components thereof.
- (2) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order
Within ninety days after the filing of an application pursuant to paragraph
(1) of this subsection, or such additional period as may be agreed upon by the
Secretary and the applicant, the Secretary shall either (A) issue an order
approving the application if he then finds that none of the grounds for denying
approval specified in paragraph (3) applies, or (B) give the applicant notice of
an opportunity for a hearing before the Secretary under paragraph (3) on the
question whether such application is approvable. The procedure governing such a
hearing shall be the procedure set forth in the last two sentences of subsection
(c) of this section.
-
(3) Grounds for refusing application; approval of application; approval
effective during existence of subsection (i) regulation
If the Secretary,
after due notice to the applicant in accordance with paragraph (2) and giving
him an opportunity for a hearing in accordance with such paragraph, finds, on
the basis of information submitted to him as part of the application or on the
basis of any other information before him -
- (A) that there is not in effect a regulation under subsection (i) of this
section (identified in such application) on the basis of which such application
may be approved;
- (B) that such animal feed (including the proposed use of any new animal
drug therein or thereon) does not conform to an applicable regulation published
pursuant to subsection (i) of this section referred to in the application, or
that the purposes and conditions or indications of use prescribed, recommended,
or suggested in the labeling of such feed do not conform to the applicable
purposes and conditions or indications of use (including warnings) published
pursuant to subsection (i) of this section or such labeling omits or fails to
conform to other applicable information published pursuant to subsection (i) of
this section;
- (C) that the methods used in, and the facilities and controls used for, the
manufacture, processing, and packing of such animal feed are inadequate to
preserve the identity, strength, quality, and purity of the new animal drug
therein; or
- (D) that, based on a fair evaluation of all material facts, such labeling
is false or misleading in any particular; he shall issue an order refusing to
approve the application. If, after such notice and opportunity for hearing, the
Secretary finds that subparagraphs (A) through (D) do not apply, he shall issue
an order approving the application. An order under this subsection approving an
application with respect to an animal feed bearing or containing a new animal
drug shall be effective only while there is in effect a regulation pursuant to
subsection (i) of this section, on the basis of which such application (or a
supplement thereto) was approved, relating to the use of such drug in or on such
feed.
- (4) Withdrawal of approval; grounds; immediate suspension upon finding
imminent hazard to health of man or animals
- (A) The Secretary shall, after due notice and opportunity for hearing to
the applicant, issue an order withdrawing approval of an application with
respect to any animal feed under this subsection if the Secretary finds -
- (i) that the application contains any untrue statement of a material fact;
or
- (ii) that the applicant has made any changes from the standpoint of safety
or effectiveness beyond the variations provided for in the application unless he
has supplemented the application by filing with the Secretary adequate
information respecting all such changes and unless there is in effect an
approval of the supplemental application. The supplemental application shall be
treated in the same manner as the original application.
If the
Secretary (or in his absence the officer acting as Secretary) finds that there
is an imminent hazard to the health of man or of the animals for which such
animal feed is intended, he may suspend the approval of such application
immediately, and give the applicant prompt notice of his action and afford the
applicant the opportunity for an expedited hearing under this subsection; but
the authority conferred by this sentence shall not be delegated.
- (B) The Secretary may also, after due notice and opportunity for hearing to
the applicant, issue an order withdrawing the approval of an application with
respect to any animal feed under this subsection if the Secretary finds -
- (i) that the applicant has failed to establish a system for maintaining
required records, or has repeatedly or deliberately failed to maintain such
records or to make required reports in accordance with a regulation or order
under paragraph (5)(A) of this subsection, or the applicant has refused to
permit access to, or copying or verification of, such records as required by
subparagraph (B) of such paragraph;
- (ii) that on the basis of new information before him, evaluated together
with the evidence before him when such application was approved, the methods
used in, or the facilities and controls used for, the manufacture, processing,
and packing of such animal feed are inadequate to assure and preserve the
identity, strength, quality, and purity of the new animal drug therein, and were
not made adequate within a reasonable time after receipt of written notice from
the Secretary, specifying the matter complained of; or
- (iii) that on the basis of new information before him, evaluated together
with the evidence before him when the application was approved, the labeling of
such animal feed, based on a fair evaluation of all material facts, is false or
misleading in any particular and was not corrected within a reasonable time
after receipt of written notice from the Secretary specifying the matter
complained of.
- (C) Any order under paragraph (4) of this subsection shall state the
findings upon which it is based.
- (5) Records and reports; regulations and orders; access to records In
the case of an animal feed for which an approval of an application filed
pursuant to this subsection is in effect -
- (A) the applicant shall establish and maintain such records, and make such
reports to the Secretary, or (at the option of the Secretary) to the appropriate
person or persons holding an approved application filed under subsection (b) of
this section, as the Secretary may by general regulation, or by order with
respect to such application, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the Secretary to determine,
or facilitate a determination, whether there is or may be ground for invoking
subsection (e) of this section or paragraph (4) of this subsection.
- (B) every person required under this subsection to maintain records, and
every person in charge or custody thereof, shall, upon request of an officer or
employee designated by the Secretary, permit such officer or employee at all
reasonable times to have access to and copy and verify such records.
- (n) Abbreviated applications for new animal drugs; contents,
filing, etc.; lists of approved drugs
For purposes of this section, the term ''patent'' means a patent issued by
the Patent and Trademark Office of the Department of Commerce.
- (p) Safety and effectiveness data
- (1) Safety and effectiveness data and information which has been submitted
in an application filed under subsection (b)(1) of this section for a drug and
which has not previously been disclosed to the public shall be made available to
the public, upon request, unless extraordinary circumstances are shown -
- (A) if no work is being or will be undertaken to have the application
approved,
- (B) if the Secretary has determined that the application is not approvable
and all legal appeals have been exhausted,
- (C) if approval of the application under subsection (c) of this section is
withdrawn and all legal appeals have been exhausted,
- (D) if the Secretary has determined that such drug is not a new drug, or
- (E) upon the effective date of the approval of the first application filed
under subsection (b)(2) of this section which refers to such drug or upon the
date upon which the approval of an application filed under subsection (b)(2) of
this section which refers to such drug could be made effective if such an
application had been filed.
- (2) Any request for data and information pursuant to paragraph (1) shall
include a verified statement by the person making the request that any data or
information received under such paragraph shall not be disclosed by such person
to any other person -
- (A) for the purpose of, or as part of a plan, scheme, or device for,
obtaining the right to make, use, or market, or making, using, or marketing,
outside the United States, the drug identified in the application filed under
subsection (b)(1) of this section, and
- (B) without obtaining from any person to whom the data and information are
disclosed an identical verified statement, a copy of which is to be provided by
such person to the Secretary, which meets the requirements of this paragraph.
§ 360c. Classification of devices intended for human use.
- (a) Classes of devices
- (1) There are established the following classes of devices intended for
human use:
- (A) Class I, General Controls. -
- (i) A device for which the controls authorized by or under section 351,
352, 360, 360f, 360h, 360i, or 360j of this title or any combination of such
sections are sufficient to provide reasonable assurance of the safety and
effectiveness of the device.
- (ii) A device for which insufficient information exists to determine that
the controls referred to in clause (i) are sufficient to provide reasonable
assurance of the safety and effectiveness of the device or to establish special
controls to provide such assurance, but because it -
- (I) is not purported or represented to be for a use in supporting or
sustaining human life or for a use which is of substantial importance in
preventing impairment of human health, and
- (II) does not present a potential unreasonable risk of illness or injury,
is to be regulated by the controls referred to in clause (i).
- (B) Class II, Special Controls. - A device which cannot be
classified as a class I device because the general controls by themselves are
insufficient to provide reasonable assurance of the safety and effectiveness of
the device, and for which there is sufficient information to establish special
controls to provide such assurance, including the promulgation of performance
standards, postmarket surveillance, patient registries, development and
dissemination of guidelines (including guidelines for the submission of clinical
data in premarket notification submissions in accordance with section 360(k) of
this title), recommendations, and other appropriate actions as the Secretary
deems necessary to provide such assurance. For a device that is purported or
represented to be for a use in supporting or sustaining human life, the
Secretary shall examine and identify the special controls, if any, that are
necessary to provide adequate assurance of safety and effectiveness and describe
how such controls provide such assurance.
- (C) Class III, Premarket Approval. - A device which because -
- (i) it (I) cannot be classified as a class I device because insufficient
information exists to determine that the application of general controls are
sufficient to provide reasonable assurance of the safety and effectiveness of
the device, and (II) cannot be classified as a class II device because
insufficient information exists to determine that the special controls described
in subparagraph (B) would provide reasonable assurance of its safety and
effectiveness, and
- (ii)(I) is purported or represented to be for a use in supporting or
sustaining human life or for a use which is of substantial importance in
preventing impairment of human health, or (II) presents a potential unreasonable
risk of illness or injury, is to be subject, in accordance with section 360e of
this title, to premarket approval to provide reasonable assurance of its safety
and effectiveness. If there is not sufficient information to establish a
performance standard for a device to provide reasonable assurance of its safety
and effectiveness, the Secretary may conduct such activities as may be necessary
to develop or obtain such information.
- (2) For purposes of this section and sections 360d and 360e of this title,
the safety and effectiveness of a device are to be determined -
- (A) with respect to the persons for whose use the device is represented or
intended,
- (B) with respect to the conditions of use prescribed, recommended, or
suggested in the labeling of the device, and
- (C) weighing any probable benefit to health from the use of the device
against any probable risk of injury or illness from such use.
- (3)
- (A) Except as authorized by subparagraph (B), the effectiveness of a device
is, for purposes of this section and sections 360d and 360e of this title, to be
determined, in accordance with regulations promulgated by the Secretary, on the
basis of well-controlled investigations, including clinical investigations where
appropriate, by experts qualified by training and experience to evaluate the
effectiveness of the device, from which investigations it can fairly and
responsibly be concluded by qualified experts that the device will have the
effect it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling of the device.
- (B) If the Secretary determines that there exists valid scientific evidence
(other than evidence derived from investigations described in subparagraph (A))
-
- (i) which is sufficient to determine the effectiveness of a device, and
- (ii) from which it can fairly and responsibly be concluded by qualified
experts that the device will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or suggested in the
labeling of the device, then, for purposes of this section and sections 360d and
360e of this title, the Secretary may authorize the effectiveness of the device
to be determined on the basis of such evidence.
- (b) Classification panels
- (1) For purposes of -
- (A) determining which devices intended for human use should be subject to
the requirements of general controls, performance standards, or premarket
approval, and
- (B) providing notice to the manufacturers and importers of such devices to
enable them to prepare for the application of such requirements to devices
manufactured or imported by them,
the Secretary shall classify all
such devices (other than devices classified by subsection (f) of this section)
into the classes established by subsection (a) of this section. For the purpose
of securing recommendations with respect to the classification of devices, the
Secretary shall establish panels of experts or use panels of experts established
before May 28, 1976, or both. Section 14 of the Federal Advisory Committee Act
shall not apply to the duration of a panel established under this paragraph.
- (2) The Secretary shall appoint to each panel established under paragraph
(1) persons who are qualified by training and experience to evaluate the safety
and effectiveness of the devices to be referred to the panel and who, to the
extent feasible, possess skill in the use of, or experience in the development,
manufacture, or utilization of, such devices. The Secretary shall make
appointments to each panel so that each panel shall consist of members with
adequately diversified expertise in such fields as clinical and administrative
medicine, engineering, biological and physical sciences, and other related
professions. In addition, each panel shall include as nonvoting members a
representative of consumer interests and a representative of interests of the
device manufacturing industry. Scientific, trade, and consumer organizations
shall be afforded an opportunity to nominate individuals for appointment to the
panels. No individual who is in the regular full-time employ of the United
States and engaged in the administration of this chapter may be a member of any
panel. The Secretary shall designate one of the members of each panel to serve
as chairman thereof.
- (3) Panel members (other than officers or employees of the United States),
while attending meetings or conferences of a panel or otherwise engaged in its
business, shall be entitled to receive compensation at rates to be fixed by the
Secretary, but not at rates exceeding the daily equivalent of the rate in effect
for grade GS-18 of the General Schedule, for each day so engaged, including
traveltime; and while so serving away from their homes or regular places of
business each member may be allowed travel expenses (including per diem in lieu
of subsistence) as authorized by section 5703 of title 5, for persons in the
Government service employed intermittently.
- (4) The Secretary shall furnish each panel with adequate clerical and other
necessary assistance.
- (c) Classification panel organization and operation
- (1) The Secretary shall organize the panels according to the various fields
of clinical medicine and fundamental sciences in which devices intended for
human use are used. The Secretary shall refer a device to be classified under
this section to an appropriate panel established or authorized to be used under
subsection (b) of this section for its review and for its recommendation
respecting the classification of the device. The Secretary shall by regulation
prescribe the procedure to be followed by the panels in making their reviews and
recommendations. In making their reviews of devices, the panels, to the maximum
extent practicable, shall provide an opportunity for interested persons to
submit data and views on the classification of the devices.
- (2)
- (A) Upon completion of a panel's review of a device referred to it under
paragraph (1), the panel shall, subject to subparagraphs (B) and (C), submit to
the Secretary its recommendation for the classification of the device. Any such
recommendation shall (i) contain (I) a summary of the reasons for the
recommendation, (II) a summary of the data upon which the recommendation is
based, and (III) an identification of the risks to health (if any) presented by
the device with respect to which the recommendation is made, and (ii) to the
extent practicable, include a recommendation for the assignment of a priority
for the application of the requirements of section 360d or 360e of this title to
a device recommended to be classified in class II or class III. •
- (B) A recommendation of a panel for the classification of a device in class
I shall include a recommendation as to whether the device should be exempted
from the requirements of section 360, 360i, or 360j(f) of this title.
- (C) In the case of a device which has been referred under paragraph (1) to
a panel, and which -
- (i) is intended to be implanted in the human body or is purported or
represented to be for a use in supporting or sustaining human life, and
- (ii)
- (I) has been introduced or delivered for introduction into interstate
commerce for commercial distribution before May 28, 1976, or
- (II) is within a type of device which was so introduced or delivered before
such date and is substantially equivalent to another device within that type,
such panel shall recommend to the Secretary that the
device be classified in class III unless the panel determines that
classification of the device in such class is not necessary to provide
reasonable assurance of its safety and effectiveness. If a panel does not
recommend that such a device be classified in class III, it shall in its
recommendation to the Secretary for the classification of the device set forth
the reasons for not recommending classification of the device in such class.
- (3) The panels shall submit to the Secretary within one year of the date
funds are first appropriated for the implementation of this section their
recommendations respecting all devices of a type introduced or delivered for
introduction into interstate commerce for commercial distribution before May 28,
1976.
- (d) Panel recommendation; publication; priorities
- (1) Upon receipt of a recommendation from a panel respecting a device, the
Secretary shall publish in the Federal Register the panel's recommendation and a
proposed regulation classifying such device and shall provide interested persons
an opportunity to submit comments on such recommendation and the proposed
regulation. After reviewing such comments, the Secretary shall, subject to
paragraph (2), by regulation classify such device.
- (2)
- (A) A regulation under paragraph (1) classifying a device in class I shall
prescribe which, if any, of the requirements of section 360, 360i, or 360j(f) of
this title shall not apply to the device. A regulation which makes a requirement
of section 360, 360i, or 360j(f) of this title inapplicable to a device shall be
accompanied by a statement of the reasons of the Secretary for making such
requirement inapplicable.
- (B) A device described in subsection (c)(2)(C) of this section shall be
classified in class III unless the Secretary determines that classification of
the device in such class is not necessary to provide reasonable assurance of its
safety and effectiveness. A proposed regulation under paragraph (1) classifying
such a device in a class other than class III shall be accompanied by a full
statement of the reasons of the Secretary (and supporting documentation and
data) for not classifying such device in such class and an identification of the
risks to health (if any) presented by such device.
- (3) In the case of devices classified in class II and devices classified
under this subsection in class III and described in section 360e(b)(1) of this
title the Secretary may establish priorities which, in his discretion, shall be
used in applying sections 360d and 360e of this title, as appropriate, to such
devices.
- (e) Classification changes
- (1) Based on new information respecting a device, the Secretary may, upon
his own initiative or upon petition of an interested person, by regulation (A)
change such device's classification, and (B) revoke, because of the change in
classification, any regulation or requirement in effect under section 360d or
360e of this title with respect to such device. In the promulgation of such a
regulation respecting a device's classification, the Secretary may secure from
the panel to which the device was last referred pursuant to subsection (c) of
this section a recommendation respecting the proposed change in the device's
classification and shall publish in the Federal Register any recommendation
submitted to the Secretary by the panel respecting such change. A regulation
under this subsection changing the classification of a device from class III to
class II may provide that such classification shall not take effect until the
effective date of a performance standard established under section 360d of this
title for such device.
- (2) By regulation promulgated under paragraph (1), the Secretary may change
the classification of a device from class III -
- (A) to class II if the Secretary determines that special controls would
provide reasonable assurance of the safety and effectiveness of the device and
that general controls would not provide reasonable assurance of the safety and
effectiveness of the device, or
- (B) to class I if the Secretary determines that general controls would
provide reasonable assurance of the safety and effectiveness of the device.
- (f) Initial classification and reclassification of certain devices
Within sixty days of the receipt of a written request of any person for
information respecting the class in which a device has been classified or the
requirements applicable to a device under this chapter, the Secretary shall
provide such person a written statement of the classification (if any) of such
device and the requirements of this chapter applicable to the device.
For purposes of this section and sections 351, 360, 360d, 360e, 360f, 360i,
and 360j of this title
- (1) a reference to ''general controls'' is a reference to the controls
authorized by or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of
this title,
- (2) a reference to ''class I'', ''class II'', or ''class III'' is a
reference to a class of medical devices described in subparagraph (A), (B), or
(C) of subsection (a)(1) of this section, and
- (3) a reference to a ''panel under section 360c of this title'' is a
reference to a panel established or authorized to be used under this section.
- (i) Substantial equivalence
- (1)
- (A) For purposes of determinations of substantial equivalence under
subsection (f) of this section and section 360j(l) of this title, the term
''substantially equivalent'' or ''substantial equivalence'' means, with respect
to a device being compared to a predicate device, that the device has the same
intended use as the predicate device and that the Secretary by order has found
that the device -
- (i) has the same technological characteristics as the predicate device, or
- (ii)
- (I) has different technological characteristics and the information
submitted that the device is substantially equivalent to the predicate device
contains information, including clinical data if deemed necessary by the
Secretary, that demonstrates that the device is as safe and effective as a
legally marketed device, and
- (II) does not raise different questions of safety and efficacy than the
predicate device.
- (B) For purposes of subparagraph (A), the term ''different technological
characteristics'' means, with respect to a device being compared to a predicate
device, that there is a significant change in the materials, design, energy
source, or other features of the device from those of the predicate device.
- (2) A device may not be found to be substantially equivalent to a predicate
device that has been removed from the market at the initiative of the Secretary
or that has been determined to be misbranded or adulterated by a judicial order.
- (3)
- (A) As part of a submission under section 360(k) of this title respecting a
device, the person required to file a premarket notification under such section
shall provide an adequate summary of any information respecting safety and
effectiveness or state that such information will be made available upon request
by any person.
- (B) Any summary under subparagraph (A) respecting a device shall contain
detailed information regarding data concerning adverse health effects and shall
be made available to the public by the Secretary within 30 days of the issuance
of a determination that such device is substantially equivalent to another
device.
§ 360d. Performance standards.
- (a) Reasonable assurance of safe and effective performance;
periodic evaluation
- (1) The special controls required by section 360c(a)(1)(B) of this title
shall include performance standards for a class II device if the Secretary
determines that a performance standard is necessary to provide reasonable
assurance of the safety and effectiveness of the device. A class III device may
also be considered a class II device for purposes of establishing a standard for
the device under this section if the device has been reclassified as a class II
device under a regulation under section 360c(e) of this title but such
regulation provides that the reclassification is not to take effect until the
effective date of such a standard for the device.
- (2) A performance standard established under this section for a device -
- (A) shall include provisions to provide reasonable assurance of its safe
and effective performance;
- (B) shall, where necessary to provide reasonable assurance of its safe and
effective performance, include -
- (i) provisions respecting the construction, components, ingredients, and
properties of the device and its compatibility with power systems and
connections to such systems,
- (ii) provisions for the testing (on a sample basis or, if necessary, on an
individual basis) of the device or, if it is determined that no other more
practicable means are available to the Secretary to assure the conformity of the
device to the standard, provisions for the testing (on a sample basis or, if
necessary, on an individual basis) by the Secretary or by another person at the
direction of the Secretary,
- (iii) provisions for the measurement of the performance characteristics of
the device,
- (iv) provisions requiring that the results of each or of certain of the
tests of the device required to be made under clause (ii) show that the device
is in conformity with the portions of the standard for which the test or tests
were required, and
- (v) a provision requiring that the sale and distribution of the device be
restricted but only to the extent that the sale and distribution of a device may
be restricted under a regulation under section 360j(e) of this title; and
- (C) shall, where appropriate, require the use and prescribe the form and
content of labeling for the proper installation, maintenance, operation, and use
of the device.
- (3) The Secretary shall provide for periodic evaluation of performance
standards established under this section to determine if such standards should
be changed to reflect new medical, scientific, or other technological data.
- (4) In carrying out his duties under this section, the Secretary shall, to
the maximum extent practicable -
- (A) use personnel, facilities, and other technical support available in
other Federal agencies,
- (B) consult with other Federal agencies concerned with standard-setting and
other nationally or internationally recognized standard-setting entities, and
- (C) invite appropriate participation, through joint or other conferences,
workshops, or other means, by informed persons representative of scientific,
professional, industry, or consumer organizations who in his judgment can make a
significant contribution.
- (b) Establishment of a standard
- (1)
- (A) The Secretary shall publish in the Federal Register a notice of
proposed rulemaking for the establishment, amendment, or revocation of any
performance standard for a device.
- (B) A notice of proposed rulemaking for the establishment or amendment of a
performance standard for a device shall -
- (i) set forth a finding with supporting justification that the performance
standard is appropriate and necessary to provide reasonable assurance of the
safety and effectiveness of the device,
- (ii) set forth proposed findings with respect to the risk of illness or
injury that the performance standard is intended to reduce or eliminate,
- (iii) invite interested persons to submit to the Secretary, within 30 days
of the publication of the notice, requests for changes in the classification of
the device pursuant to section 360c(e) of this title based on new information
relevant to the classification, and
- (iv) invite interested persons to submit an existing performance standard
for the device, including a draft or proposed performance standard, for
consideration by the Secretary.
- (C) A notice of proposed rulemaking for the revocation of a performance
standard shall set forth a finding with supporting justification that the
performance standard is no longer necessary to provide reasonable assurance of
the safety and effectiveness of a device.
- (D) The Secretary shall provide for a comment period of not less than 60
days.
- (2) If, after publication of a notice in accordance with paragraph (1), the
Secretary receives a request for a change in the classification of the device,
the Secretary shall, within 60 days of the publication of the notice, after
consultation with the appropriate panel under section 360c of this title, either
deny the request or give notice of an intent to initiate such change under
section 360c(e) of this title.
- (3)
- (A) After the expiration of the period for comment on a notice of proposed
rulemaking published under paragraph (1) respecting a performance standard and
after consideration of such comments and any report from an advisory committee
under paragraph (5), the Secretary shall (i) promulgate a regulation
establishing a performance standard and publish in the Federal Register findings
on the matters referred to in paragraph (1), or (ii) publish a notice
terminating the proceeding for the development of the standard together with the
reasons for such termination. If a notice of termination is published, the
Secretary shall (unless such notice is issued because the device is a banned
device under section 360f of this title) initiate a proceeding under section
360c(e) of this title to reclassify the device subject to the proceeding
terminated by such notice.
- (B) A regulation establishing a performance standard shall set forth the
date or dates upon which the standard shall take effect, but no such regulation
may take effect before one year after the date of its publication unless (i) the
Secretary determines that an earlier effective date is necessary for the
protection of the public health and safety, or (ii) such standard has been
established for a device which, effective upon the effective date of the
standard, has been reclassified from class III to class II. Such date or dates
shall be established so as to minimize, consistent with the public health and
safety, economic loss to, and disruption or dislocation of, domestic and
international trade.
- (4)
- (A) The Secretary, upon his own initiative or upon petition of an
interested person may by regulation, promulgated in accordance with the
requirements of paragraphs (1), (2), and (3)(B) of this subsection, amend or
revoke a performance standard.
- (B) The Secretary may declare a proposed amendment of a performance
standard to be effective on and after its publication in the Federal Register
and until the effective date of any final action taken on such amendment if he
determines that making it so effective is in the public interest. A proposed
amendment of a performance standard made so effective under the preceding
sentence may not prohibit, during the period in which it is so effective, the
introduction or delivery for introduction into interstate commerce of a device
which conforms to such standard without the change or changes provided by such
proposed amendment.
- (5)
- (A) The Secretary -
- (i) may on his own initiative refer a proposed regulation for the
establishment, amendment, or revocation of a performance standard, or
- (ii) shall, upon the request of an interested person which demonstrates
good cause for referral and which is made before the expiration of the period
for submission of comments on such proposed regulation refer such proposed
regulation, to an advisory committee of experts, established pursuant to
subparagraph (B), for a report and recommendation with respect to any matter
involved in the proposed regulation which requires the exercise of scientific
judgment. If a proposed regulation is referred under this subparagraph to an
advisory committee, the Secretary shall provide the advisory committee with the
data and information on which such proposed regulation is based. The advisory
committee shall, within sixty days of the referral of a proposed regulation and
after independent study of the data and information furnished to it by the
Secretary and other data and information before it, submit to the Secretary a
report and recommendation respecting such regulation, together with all
underlying data and information and a statement of the reason or basis for the
recommendation. A copy of such report and recommendation shall be made public by
the Secretary.
- (B) The Secretary shall establish advisory committees (which may not be
panels under section 360c of this title) to receive referrals under subparagraph
(A). The Secretary shall appoint as members of any such advisory committee
persons qualified in the subject matter to be referred to the committee and of
appropriately diversified professional background, except that the Secretary may
not appoint to such a committee any individual who is in the regular full-time
employ of the United States and engaged in the administration of this chapter.
Each such committee shall include as nonvoting members a representative of
consumer interests and a representative of interests of the device manufacturing
industry. Members of an advisory committee who are not officers or employees of
the United States, while attending conferences or meetings of their committee or
otherwise serving at the request of the Secretary, shall be entitled to receive
compensation at rates to be fixed by the Secretary, which rates may not exceed
the daily equivalent of the rate in effect for grade GS-18 of the General
Schedule, for each day (including traveltime) they are so engaged; and while so
serving away from their homes or regular places of business each member may be
allowed travel expenses, including per diem in lieu of subsistence, as
authorized by section 5703 of title 5 for persons in the Government service
employed intermittently. The Secretary shall designate one of the members of
each advisory committee to serve as chairman thereof. The Secretary shall
furnish each advisory committee with clerical and other assistance, and shall by
regulation prescribe the procedures to be followed by each such committee in
acting on referrals made under subparagraph (A).
§ 360e. Premarket approval.
A class III device -
- (1) which is subject to a regulation promulgated under subsection (b)
of this section; or
- (2) which is a class III device because of section 360c(f) of this title,
is required to have, unless exempt under section 360j(g) of this title, an
approval under this section of an application for premarket approval.
- (b) Regulation to require premarket approval
- (1) In the case of a class III device which -
- (A) was introduced or delivered for introduction into interstate commerce
for commercial distribution before May 28, 1976; or
- (B) is (i) of a type so introduced or delivered, and (ii) is substantially
equivalent to another device within that type, the Secretary shall by
regulation, promulgated in accordance with this subsection, require that such
device have an approval under this section of an application for premarket
approval.
- (2)
- (A) A proceeding for the promulgation of a regulation under paragraph (1)
respecting a device shall be initiated by the publication in the Federal
Register of a notice of proposed rulemaking. Such notice shall contain -
- (i) the proposed regulation;
- (ii) proposed findings with respect to the degree of risk of illness or
injury designed to be eliminated or reduced by requiring the device to have an
approved application for premarket approval and the benefit to the public from
use of the device;
- (iii) opportunity for the submission of comments on the proposed regulation
and the proposed findings; and
- (iv) opportunity to request a change in the classification of the device
based on new information relevant to the classification of the device.
- (B) If, within fifteen days after publication of a notice under
subparagraph (A), the Secretary receives a request for a change in the
classification of a device, he shall, within sixty days of the publication of
such notice and after consultation with the appropriate panel under section 360c
of this title, by order published in the Federal Register, either deny the
request for change in classification or give notice of his intent to initiate
such a change under section 360c(e) of this title.
- (3) After the expiration of the period for comment on a proposed regulation
and proposed findings published under paragraph (2) and after consideration of
comments submitted on such proposed regulation and findings, the Secretary shall
(A) promulgate such regulation and publish in the Federal Register findings on
the matters referred to in paragraph (2)(A)(ii), or (B) publish a notice
terminating the proceeding for the promulgation of the regulation together with
the reasons for such termination. If a notice of termination is published, the
Secretary shall (unless such notice is issued because the device is a banned
device under section 360f of this title) initiate a proceeding under section
360c(e) of this title to reclassify the device subject to the proceeding
terminated by such notice.
- (4) The Secretary, upon his own initiative or upon petition of an
interested person, may by regulation amend or revoke any regulation promulgated
under this subsection. A regulation to amend or revoke a regulation under this
subsection shall be promulgated in accordance with the requirements prescribed
by this subsection for the promulgation of the regulation to be amended or
revoked.
- (c) Application for premarket approval
- (1) Any person may file with the Secretary an application for premarket
approval for a class III device. Such an application for a device shall contain
-
- (A) full reports of all information, published or known to or which should
reasonably be known to the applicant, concerning investigations which have been
made to show whether or not such device is safe and effective;
- (B) a full statement of the components, ingredients, and properties and of
the principle or principles of operation, of such device;
- (C) a full description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and, when relevant, packing and
installation of, such device;
- (D) an identifying reference to any performance standard under section 360d
of this title which would be applicable to any aspect of such device if it were
a class II device, and either adequate information to show that such aspect of
such device fully meets such performance standard or adequate information to
justify any deviation from such standard;
- (E) such samples of such device and of components thereof as the Secretary
may reasonably require, except that where the submission of such samples is
impracticable or unduly burdensome, the requirement of this subparagraph may be
met by the submission of complete information concerning the location of one or
more such devices readily available for examination and testing;
- (F) specimens of the labeling proposed to be used for such device; and
- (G) such other information relevant to the subject matter of the
application as the Secretary, with the concurrence of the appropriate panel
under section 360c of this title, may require.
- (2) Upon receipt of an application meeting the requirements set forth in
paragraph (1), the Secretary -
- (A) may on the Secretary's own initiative, or
- (B) shall, upon the request of an applicant unless the Secretary finds that
the information in the application which would be reviewed by a panel
substantially duplicates information which has previously been reviewed by a
panel appointed under section 360c of this title,
refer such application to the appropriate panel under section 360c
of this title for study and for submission (within such period as he may
establish) of a report and recommendation respecting approval of the
application, together with all underlying data and the reasons or basis for the
recommendation.
- (d) Action on application for premarket approval
- (1)
- (A) As promptly as possible, but in no event later than one hundred and
eighty days after the receipt of an application under subsection (c) of this
section (except as provided in section 360j(l)(3)(D)(ii) of this title or
unless, in accordance with subparagraph (B)(i), an additional period as agreed
upon by the Secretary and the applicant), the Secretary, after considering the
report and recommendation submitted under paragraph (2) of such subsection,
shall -
- (i) issue an order approving the application if he finds that none of the
grounds for denying approval specified in paragraph (2) of this subsection
applies; or
- (ii) deny approval of the application if he finds (and sets forth the basis
for such finding as part of or accompanying such denial) that one or more
grounds for denial specified in paragraph (2) of this subsection apply.
- (B)
- (i) The Secretary may not enter into an agreement to extend the period in
which to take action with respect to an application submitted for a device
subject to a regulation promulgated under subsection (b) of this section unless
he finds that the continued availability of the device is necessary for the
public health.
- (ii) An order approving an application for a device may require as a
condition to such approval that the sale and distribution of the device be
restricted but only to the extent that the sale and distribution of a device may
be restricted under a regulation under section 360j(e) of this title.
- (2) The Secretary shall deny approval of an application for a device if,
upon the basis of the information submitted to the Secretary as part of the
application and any other information before him with respect to such device,
the Secretary finds that -
- (A) there is a lack of a showing of reasonable assurance that such device
is safe under the conditions of use prescribed, recommended, or suggested in the
proposed labeling thereof;
- (B) there is a lack of a showing of reasonable assurance that the device is
effective under the conditions of use prescribed, recommended, or suggested in
the proposed labeling thereof;
- (C) the methods used in, or the facilities or controls used for, the
manufacture, processing, packing, or installation of such device do not conform
to the requirements of section 360j(f) of this title;
- (D) based on a fair evaluation of all material facts, the proposed labeling
is false or misleading in any particular; or
- (E) such device is not shown to conform in all respects to a performance
standard in effect under section 360d of this title compliance with which is a
condition to approval of the application and there is a lack of adequate
information to justify the deviation from such standard.
Any
denial of an application shall, insofar as the Secretary determines to be
practicable, be accompanied by a statement informing the applicant of the
measures required to place such application in approvable form (which measures
may include further research by the applicant in accordance with one or more
protocols prescribed by the Secretary).
- (3) An applicant whose application has been denied approval may, by
petition filed on or before the thirtieth day after the date upon which he
receives notice of such denial, obtain review thereof in accordance with either
paragraph (1) or (2) of subsection (g) of this section, and any interested
person may obtain review, in accordance with paragraph (1) or (2) of subsection
(g) of this section, of an order of the Secretary approving an application.
- (e) Withdrawal and temporary suspension of approval of application
- (1) The Secretary shall, upon obtaining, where appropriate, advice on
scientific matters from a panel or panels under section 360c of this title, and
after due notice and opportunity for informal hearing to the holder of an
approved application for a device, issue an order withdrawing approval of the
application if the Secretary finds -
- (A) that such device is unsafe or ineffective under the conditions of use
prescribed, recommended, or suggested in the labeling thereof;
- (B) on the basis of new information before him with respect to such device,
evaluated together with the evidence available to him when the application was
approved, that there is a lack of a showing of reasonable assurance that the
device is safe or effective under the conditions of use prescribed, recommended,
or suggested in the labeling thereof;
- (C) that the application contained or was accompanied by an untrue
statement of a material fact;
- (D) that the applicant (i) has failed to establish a system for maintaining
records, or has repeatedly or deliberately failed to maintain records or to make
reports, required by an applicable regulation under section 360i(a) of this
title, (ii) has refused to permit access to, or copying or verification of, such
records as required by section 374 of this title, or (iii) has not complied with
the requirements of section 360 of this title;
- (E) on the basis of new information before him with respect to such device,
evaluated together with the evidence before him when the application was
approved, that the methods used in, or the facilities and controls used for, the
manufacture, processing, packing, or installation of such device do not conform
with the requirements of section 360j(f) of this title and were not brought into
conformity with such requirements within a reasonable time after receipt of
written notice from the Secretary of nonconformity;
- (F) on the basis of new information before him, evaluated together with the
evidence before him when the application was approved, that the labeling of such
device, based on a fair evaluation of all material facts, is false or misleading
in any particular and was not corrected within a reasonable time after receipt
of written notice from the Secretary of such fact; or
- (G) on the basis of new information before him, evaluated together with the
evidence before him when the application was approved, that such device is not
shown to conform in all respects to a performance standard which is in effect
under section 360d of this title compliance with which was a condition to
approval of the application and that there is a lack of adequate information to
justify the deviation from such standard.
- (2) The holder of an application subject to an order issued under paragraph
(1) withdrawing approval of the application may, by petition filed on or before
the thirtieth day after the date upon which he receives notice of such
withdrawal, obtain review thereof in accordance with either paragraph (1) or (2)
of subsection (g) of this section.
- (3) If, after providing an opportunity for an informal hearing, the
Secretary determines there is reasonable probability that the continuation of
distribution of a device under an approved application would cause serious,
adverse health consequences or death, the Secretary shall by order temporarily
suspend the approval of the application approved under this section. If the
Secretary issues such an order, the Secretary shall proceed expeditiously under
paragraph (1) to withdraw such application.
- (f) Product development protocol
- (1) In the case of a class III device which is required to have an approval
of an application submitted under subsection (c) of this section, such device
shall be considered as having such an approval if a notice of completion of
testing conducted in accordance with a product development protocol approved
under paragraph (4) has been declared completed under paragraph (6).
- (2) Any person may submit to the Secretary a proposed product development
protocol with respect to a device. Such a protocol shall be accompanied by data
supporting it. If, within thirty days of the receipt of such a protocol, the
Secretary determines that it appears to be appropriate to apply the requirements
of this subsection to the device with respect to which the protocol is
submitted, he shall refer the proposed protocol to the appropriate panel under
section 360c of this title for its recommendation respecting approval of the
protocol.
- (3) A proposed product development protocol for a device may be approved
only if -
- (A) the Secretary determines that it is appropriate to apply the
requirements of this subsection to the device in lieu of the requirement of
approval of an application submitted under subsection (c) of this section; and
- (B) the Secretary determines that the proposed protocol provides -
- (i) a description of the device and the changes which may be made in the
device,
- (ii) a description of the preclinical trials (if any) of the device and a
specification of (I) the results from such trials to be required before the
commencement of clinical trials of the device, and (II) any permissible
variations in preclinical trials and the results therefrom,
- (iii) a description of the clinical trials (if any) of the device and a
specification of (I) the results from such trials to be required before the
filing of a notice of completion of the requirements of the protocol, and (II)
any permissible variations in such trials and the results therefrom,
- (iv) a description of the methods to be used in, and the facilities and
controls to be used for, the manufacture, processing, and, when relevant,
packing and installation of the device,
- (v) an identifying reference to any performance standard under section 360d
of this title to be applicable to any aspect of such device,
- (vi) if appropriate, specimens of the labeling proposed to be used for such
device,
- (vii) such other information relevant to the subject matter of the protocol
as the Secretary, with the concurrence of the appropriate panel or panels under
section 360c of this title, may require, and
- (viii) a requirement for submission of progress reports and, when
completed, records of the trials conducted under the protocol which records are
adequate to show compliance with the protocol.
- (4) The Secretary shall approve or disapprove a proposed product
development protocol submitted under paragraph (2) within one hundred and twenty
days of its receipt unless an additional period is agreed upon by the Secretary
and the person who submitted the protocol. Approval of a protocol or denial of
approval of a protocol is final agency action subject to judicial review under
chapter 7 of title 5.
- (5) At any time after a product development protocol for a device has been
approved pursuant to paragraph (4), the person for whom the protocol was
approved may submit a notice of completion -
- (A) stating (i) his determination that the requirements of the protocol
have been fulfilled and that, to the best of his knowledge, there is no reason
bearing on safety or effectiveness why the notice of completion should not
become effective, and (ii) the data and other information upon which such
determination was made, and
- (B) setting forth the results of the trials required by the protocol and
all the information required by subsection (c)(1) of this section.
- (6)
- (A) The Secretary may, after providing the person who has an approved
protocol and opportunity for an informal hearing and at any time prior to
receipt of notice of completion of such protocol, issue a final order to revoke
such protocol if he finds that -
- (i) such person has failed substantially to comply with the requirements of
the protocol,
- (ii) the results of the trials obtained under the protocol differ so
substantially from the results required by the protocol that further trials
cannot be justified, or
- (iii) the results of the trials conducted under the protocol or available
new information do not demonstrate that the device tested under the protocol
does not present an unreasonable risk to health and safety.
- (B) After the receipt of a notice of completion of an approved protocol the
Secretary shall, within the ninety-day period beginning on the date such notice
is received, by order either declare the protocol completed or declare it not
completed. An order declaring a protocol not completed may take effect only
after the Secretary has provided the person who has the protocol opportunity for
an informal hearing on the order. Such an order may be issued only if the
Secretary finds -
- (i) such person has failed substantially to comply with the requirements of
the protocol,
- (ii) the results of the trials obtained under the protocol differ
substantially from the results required by the protocol, or
- (iii) there is a lack of a showing of reasonable assurance of the safety
and effectiveness of the device under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof.
- (C) A final order issued under subparagraph (A) or (B) shall be in writing
and shall contain the reasons to support the conclusions thereof.
- (7) At any time after a notice of completion has become effective, the
Secretary may issue an order (after due notice and opportunity for an informal
hearing to the person for whom the notice is effective) revoking the approval of
a device provided by a notice of completion which has become effective as
provided in subparagraph (B) if he finds that any of the grounds listed in
subparagraphs (A) through (G) of subsection (e)(1) of this section apply. Each
reference in such subparagraphs to an application shall be considered for
purposes of this paragraph as a reference to a protocol and the notice of
completion of such protocol, and each reference to the time when an application
was approved shall be considered for purposes of this paragraph as a reference
to the time when a notice of completion took effect.
- (8) A person who has an approved protocol subject to an order issued under
paragraph (6)(A) revoking such protocol, a person who has an approved protocol
with respect to which an order under paragraph (6)(B) was issued declaring that
the protocol had not been completed, or a person subject to an order issued
under paragraph (7) revoking the approval of a device may, by petition filed on
or before the thirtieth day after the date upon which he receives notice of such
order, obtain review thereof in accordance with either paragraph (1) or (2) of
subsection (g) of this section.
- (g) Review
- (1) Upon petition for review of -
- (A) an order under subsection (d) of this section approving or denying
approval of an application or an order under subsection (e) of this section
withdrawing approval of an application, or
- (B) an order under subsection (f)(6)(A) of this section revoking an
approved protocol, under subsection (f)(6)(B) of this section declaring that an
approved protocol has not been completed, or under subsection (f)(7) of this
section revoking the approval of a device,
the Secretary shall,
unless he finds the petition to be without good cause or unless a petition for
review of such order has been submitted under paragraph (2), hold a hearing, in
accordance with section 554 of title 5, on the order. The panel or panels which
considered the application, protocol, or device subject to such order shall
designate a member to appear and testify at any such hearing upon request of the
Secretary, the petitioner, or the officer conducting the hearing, but this
requirement does not preclude any other member of the panel or panels from
appearing and testifying at any such hearing. Upon completion of such hearing
and after considering the record established in such hearing, the Secretary
shall issue an order either affirming the order subject to the hearing or
reversing such order and, as appropriate, approving or denying approval of the
application, reinstating the application's approval, approving the protocol, or
placing in effect a notice of completion.
- (2)
- (A) Upon petition for review of -
- (i) an order under subsection (d) of this section approving or denying
approval of an application or an order under subsection (e) of this section
withdrawing approval of an application, or
- (ii) an order under subsection (f)(6)(A) of this section revoking an
approved protocol, under subsection (f)(6)(B) of this section declaring that an
approved protocol has not been completed, or under subsection (f)(7) of this
section revoking the approval of a device,
the Secretary shall
refer the application or protocol subject to the order and the basis for the
order to an advisory committee of experts established pursuant to subparagraph
(B) for a report and recommendation with respect to the order. The advisory
committee shall, after independent study of the data and information furnished
to it by the Secretary and other data and information before it, submit to the
Secretary a report and recommendation, together with all underlying data and
information and a statement of the reasons or basis for the recommendation. A
copy of such report shall be promptly supplied by the Secretary to any person
who petitioned for such referral to the advisory committee.
- (B) The Secretary shall establish advisory committees (which may not be
panels under section 360c of this title) to receive referrals under subparagraph
(A). The Secretary shall appoint as members of any such advisory committee
persons qualified in the subject matter to be referred to the committee and of
appropriately diversified professional backgrounds, except that the Secretary
may not appoint to such a committee any individual who is in the regular
full-time employ of the United States and engaged in the administration of this
chapter. Members of an advisory committee (other than officers or employees of
the United States), while attending conferences or meetings of their committee
or otherwise serving at the request of the Secretary, shall be entitled to
receive compensation at rates to be fixed by the Secretary, which rates may not
exceed the daily equivalent for grade GS-18 of the General Schedule for each day
(including traveltime) they are so engaged; and while so serving away from their
homes or regular places of business each member may be allowed travel expenses,
including per diem in lieu of subsistence, as authorized by section 5703 of
title 5 for persons in the Government service employed intermittently. The
Secretary shall designate the chairman of an advisory committee from its
members. The Secretary shall furnish each advisory committee with clerical and
other assistance, and shall by regulation prescribe the procedures to be
followed by each such committee in acting on referrals made under subparagraph
(A).
- (C) The Secretary shall make public the report and recommendation made by
an advisory committee with respect to an application and shall by order, stating
the reasons therefor, either affirm the order referred to the advisory committee
or reverse such order and, if appropriate, approve or deny approval of the
application, reinstate the application's approval, approve the protocol, or
place in effect a notice of completion.
Orders of the Secretary under this section shall be served (1) in person by
any officer or employee of the department designated by the Secretary, or (2) by
mailing the order by registered mail or certified mail addressed to the
applicant at his last known address in the records of the Secretary.
- (i) Revision
- (1) Before December 1, 1995, the Secretary shall by order require
manufacturers of devices, which were introduced or delivered for introduction
into interstate commerce for commercial distribution before May 28, 1976, and
which are subject to revision of classification under paragraph (2), to submit
to the Secretary a summary of and citation to any information known or otherwise
available to the manufacturer respecting such devices, including adverse safety
or effectiveness information which has not been submitted under section 360i of
this title. The Secretary may require the manufacturer to submit the adverse
safety or effectiveness data for which a summary and citation were submitted, if
such data are available to the manufacturer.
- (2) After the issuance of an order under paragraph (1) but before December
1, 1995, the Secretary shall publish a regulation in the Federal Register for
each device -
- (A) which the Secretary has classified as a class III device, and
- (B) for which no final regulation has been promulgated under subsection (b)
of this section, revising the classification of the device so that the device is
classified into class I or class II, unless the regulation requires the device
to remain in class III. In determining whether to revise the classification of a
device or to require a device to remain in class III, the Secretary shall apply
the criteria set forth in section 360c(a) of this title. Before the publication
of a regulation requiring a device to remain in class III or revising its
classification, the Secretary shall publish a proposed regulation respecting the
classification of a device under this paragraph and provide reasonable
opportunity for the submission of comments on any such regulation. No regulation
requiring a device to remain in class III or revising its classification may
take effect before the expiration of 90 days from the date of its publication in
the Federal Register as a proposed regulation.
- (3) The Secretary shall, as promptly as is reasonably achievable, but not
later than 12 months after the effective date of the regulation requiring a
device to remain in class III, establish a schedule for the promulgation of a
subsection (b) of this section regulation for each device which is subject to
the regulation requiring the device to remain in class III.
§ 360f. Banned devices.
Whenever the Secretary finds, on the basis of all available data and
information, that -
- (1) a device intended for human use presents substantial deception or
an unreasonable and substantial risk of illness or injury; and
- (2) in the case of substantial deception or an unreasonable and substantial
risk of illness or injury which the Secretary determined could be corrected or
eliminated by labeling or change in labeling and with respect to which the
Secretary provided written notice to the manufacturer specifying the deception
or risk of illness or injury, the labeling or change in labeling to correct the
deception or eliminate or reduce such risk, and the period within which such
labeling or change in labeling was to be done, such labeling or change in
labeling was not done within such period; he may initiate a proceeding to
promulgate a regulation to make such device a banned device.
- (b) Special effective date
The Secretary may declare a proposed regulation under subsection (a) of this
section to be effective upon its publication in the Federal Register and until
the effective date of any final action taken respecting such regulation if (1)
he determines, on the basis of all available data and information, that the
deception or risk of illness or injury associated with the use of the device
which is subject to the regulation presents an unreasonable, direct, and
substantial danger to the health of individuals, and (2) before the date of the
publication of such regulation, the Secretary notifies the manufacturer of such
device that such regulation is to be made so effective. If the Secretary makes a
proposed regulation so effective, he shall, as expeditiously as possible, give
interested persons prompt notice of his action under this subsection, provide
reasonable opportunity for an informal hearing on the proposed regulation, and
either affirm, modify, or revoke such proposed regulation.
§ 360g. Judicial review.
Not later than thirty days after -
- (1) the promulgation of a regulation under section 360c of this title
classifying a device in class I or changing the classification of a device to
class I or an order under subsection (f)(2) of such section reclassifying a
device or denying a petition for reclassification of a device,
- (2) the promulgation of a regulation under section 360d of this title
establishing, amending, or revoking a performance standard for a device,
- (3) the issuance of an order under section 360d(b)(2) or 360e(b)(2)(B) of
this title denying a request for reclassification of a device,
- (4) the promulgation of a regulation under paragraph (3) of section 360e(b)
of this title requiring a device to have an approval of a premarket application,
a regulation under paragraph (4) of that section amending or revoking a
regulation under paragraph (3), or an order pursuant to section 360e(g)(1) or
360e(g)(2)(C) of this title,
- (5) the promulgation of a regulation under section 360f of this title
(other than a proposed regulation made effective under subsection (b) of such
section upon the regulation's publication) making a device a banned device,
- (6) the issuance of an order under section 360j(f)(2) of this title,
- (7) an order under section 360j(g)(4) of this title disapproving an
application for an exemption of a device for investigational use or an order
under section 360j(g)(5) of this title withdrawing such an exemption for a
device,
- (8) an order pursuant to section 360c(i) of this title,
- (9) a regulation under section 360e(i)(2) or 360j(l)(5)(B) of this title,
or
- (10) an order under section 360j(h)(4)(B) of this title,
any person adversely affected by such regulation or order may file a
petition with the United States Court of Appeals for the District of Columbia or
for the circuit wherein such person resides or has his principal place of
business for judicial review of such regulation or order. A copy of the petition
shall be transmitted by the clerk of the court to the Secretary or other officer
designated by him for that purpose. The Secretary shall file in the court the
record of the proceedings on which the Secretary based his regulation or order
as provided in section 2112 of title 28. For purposes of this section, the term
''record'' means all notices and other matter published in the Federal Register
with respect to the regulation or order reviewed, all information submitted to
the Secretary with respect to such regulation or order, proceedings of any panel
or advisory committee with respect to such regulation or order, any hearing held
with respect to such regulation or order, and any other information identified
by the Secretary, in the administrative proceeding held with respect to such
regulation or order, as being relevant to such regulation or order.
- (b) Additional data, views, and arguments
If the petitioner applies to the court for leave to adduce additional data,
views, or arguments respecting the regulation or order being reviewed and shows
to the satisfaction of the court that such additional data, views, or arguments
are material and that there were reasonable grounds for the petitioner's failure
to adduce such data, views, or arguments in the proceedings before the
Secretary, the court may order the Secretary to provide additional opportunity
for the oral presentation of data, views, or arguments and for written
submissions. The Secretary may modify his findings, or make new findings by
reason of the additional data, views, or arguments so taken and shall file with
the court such modified or new findings, and his recommendation, if any, for the
modification or setting aside of the regulation or order being reviewed, with
the return of such additional data, views, or arguments.
Upon the filing of the petition under subsection (a) of this section for
judicial review of a regulation or order, the court shall have jurisdiction to
review the regulation or order in accordance with chapter 7 of title 5 and to
grant appropriate relief, including interim relief, as provided in such chapter.
A regulation described in paragraph (2) or (5) of subsection (a) of this section
and an order issued after the review provided by section 360e(g) of this title
shall not be affirmed if it is found to be unsupported by substantial evidence
on the record taken as a whole.
- (d) Finality of judgments
The judgment of the court affirming or setting aside, in whole or in part,
any regulation or order shall be final, subject to review by the Supreme Court
of the United States upon certiorari or certification, as provided in section
1254 of title 28.
The remedies provided for in this section shall be in addition to and not in
lieu of any other remedies provided by law.
To facilitate judicial review under this section or under any other
provision of law of a regulation or order issued under section 360c, 360d, 360e,
360f, 360h, 360i, 360j, or 360k of this title each such regulation or order
shall contain a statement of the reasons for its issuance and the basis, in the
record of the proceedings held in connection with its issuance, for its
issuance.
§ 360h. Notification and other remedies.
If the Secretary determines that -
- (1) a device intended for human use which is introduced or delivered
for introduction into interstate commerce for commercial distribution presents
an unreasonable risk of substantial harm to the public health, and
- (2) notification under this subsection is necessary to eliminate the
unreasonable risk of such harm and no more practicable means is available under
the provisions of this chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure that
adequate notification is provided in an appropriate form, by the persons and
means best suited under the circumstances involved, to all health professionals
who prescribe or use the device and to any other person (including
manufacturers, importers, distributors, retailers, and device users) who should
properly receive such notification in order to eliminate such risk. An order
under this subsection shall require that the individuals subject to the risk
with respect to which the order is to be issued be included in the persons to be
notified of the risk unless the Secretary determines that notice to such
individuals would present a greater danger to the health of such individuals
than no such notification. If the Secretary makes such a determination with
respect to such individuals, the order shall require that the health
professionals who prescribe or use the device provide for the notification of
the individuals whom the health professionals treated with the device of the
risk presented by the device and of any action which may be taken by or on
behalf of such individuals to eliminate or reduce such risk. Before issuing an
order under this subsection, the Secretary shall consult with the persons who
are to give notice under the order.
- (b) Repair, replacement, or refund
- (1)
- (A) If, after affording opportunity for an informal hearing, the Secretary
determines that -
- (i) a device intended for human use which is introduced or delivered for
introduction into interstate commerce for commercial distribution presents an
unreasonable risk of substantial harm to the public health,
- (ii) there are reasonable grounds to believe that the device was not
properly designed or manufactured with reference to the state of the art as it
existed at the time of its design or manufacture,
- (iii) there are reasonable grounds to believe that the unreasonable risk
was not caused by failure of a person other than a manufacturer, importer,
distributor, or retailer of the device to exercise due care in the installation,
maintenance, repair, or use of the device, and
- (iv) the notification authorized by subsection (a) of this section would
not by itself be sufficient to eliminate the unreasonable risk and action
described in paragraph (2) of this subsection is necessary to eliminate such
risk,
the Secretary may order the manufacturer, importer, or any
distributor of such device, or any combination of such persons, to submit to him
within a reasonable time a plan for taking one or more of the actions described
in paragraph (2). An order issued under the preceding sentence which is directed
to more than one person shall specify which person may decide which action shall
be taken under such plan and the person specified shall be the person who the
Secretary determines bears the principal, ultimate financial responsibility for
action taken under the plan unless the Secretary cannot determine who bears such
responsibility or the Secretary determines that the protection of the public
health requires that such decision be made by a person (including a device user
or health professional) other than the person he determines bears such
responsibility.
- (B) The Secretary shall approve a plan submitted pursuant to an order
issued under subparagraph (A) unless he determines (after affording opportunity
for an informal hearing) that the action or actions to be taken under the plan
or the manner in which such action or actions are to be taken under the plan
will not assure that the unreasonable risk with respect to which such order was
issued will be eliminated. If the Secretary disapproves a plan, he shall order a
revised plan to be submitted to him within a reasonable time. If the Secretary
determines (after affording opportunity for an informal hearing) that the
revised plan is unsatisfactory or if no revised plan or no initial plan has been
submitted to the Secretary within the prescribed time, the Secretary shall (i)
prescribe a plan to be carried out by the person or persons to whom the order
issued under subparagraph (A) was directed, or (ii) after affording an
opportunity for an informal hearing, by order prescribe a plan to be carried out
by a person who is a manufacturer, importer, distributor, or retailer of the
device with respect to which the order was issued but to whom the order under
subparagraph (A) was not directed.
- (2) The actions which may be taken under a plan submitted under an order
issued under paragraph (1) are as follows:
- (A) To repair the device so that it does not present the unreasonable risk
of substantial harm with respect to which the order under paragraph (1) was
issued.
- (B) To replace the device with a like or equivalent device which is in
conformity with all applicable requirements of this chapter.
- (C) To refund the purchase price of the device (less a reasonable allowance
for use if such device has been in the possession of the device user for one
year or more -
- (i) at the time of notification ordered under subsection (a) of this
section, or
- (ii) at the time the device user receives actual notice of the unreasonable
risk with respect to which the order was issued under paragraph (1), whichever
first occurs).
- (3) No charge shall be made to any person (other than a manufacturer,
importer, distributor or retailer) for availing himself of any remedy, described
in paragraph (2) and provided under an order issued under paragraph (1), and the
person subject to the order shall reimburse each person (other than a
manufacturer, importer, distributor, or retailer) who is entitled to such a
remedy for any reasonable and foreseeable expenses actually incurred by such
person in availing himself of such remedy.
An order issued under subsection (b) of this section with respect to a
device may require any person who is a manufacturer, importer, distributor, or
retailer of the device to reimburse any other person who is a manufacturer,
importer, distributor, or retailer of such device for such other person's
expenses actually incurred in connection with carrying out the order if the
Secretary determines such reimbursement is required for the protection of the
public health. Any such requirement shall not affect any rights or obligations
under any contract to which the person receiving reimbursement or the person
making such reimbursement is a party.
- (d) Effect on other liability
Compliance with an order issued under this section shall not relieve any
person from liability under Federal or State law. In awarding damages for
economic loss in an action brought for the enforcement of any such liability,
the value to the plaintiff in such action of any remedy provided him under such
order shall be taken into account.
- (e) Recall authority
- (1) If the Secretary finds that there is a reasonable probability that a
device intended for human use would cause serious, adverse health consequences
or death, the Secretary shall issue an order requiring the appropriate person
(including the manufacturers, importers, distributors, or retailers of the
device) -
- (A) to immediately cease distribution of such device, and
- (B) to immediately notify health professionals and device user facilities
of the order and to instruct such professionals and facilities to cease use of
such device. The order shall provide the person subject to the order with an
opportunity for an informal hearing, to be held not later than 10 days after the
date of the issuance of the order, on the actions required by the order and on
whether the order should be amended to require a recall of such device. If,
after providing an opportunity for such a hearing, the Secretary determines that
inadequate grounds exist to support the actions required by the order, the
Secretary shall vacate the order.
- (2)
- (A) If, after providing an opportunity for an informal hearing under
paragraph (1), the Secretary determines that the order should be amended to
include a recall of the device with respect to which the order was issued, the
Secretary shall, except as provided in subparagraphs (B) and (C), amend the
order to require a recall. The Secretary shall specify a timetable in which the
device recall will occur and shall require periodic reports to the Secretary
describing the progress of the recall.
- (B) An amended order under subparagraph (A) -
- (i) shall -
- (I) not include recall of a device from individuals, and
- (II) not include recall of a device from device user facilities if the
Secretary determines that the risk of recalling such device from the facilities
presents a greater health risk than the health risk of not recalling the device
from use, and
- (ii) shall provide for notice to individuals subject to the risks
associated with the use of such device. In providing the notice required by
clause (ii), the Secretary may use the assistance of health professionals who
prescribed or used such a device for individuals. If a significant number of
such individuals cannot be identified, the Secretary shall notify such
individuals pursuant to section 375(b) of this title.
- (3) The remedy provided by this subsection shall be in addition to remedies
provided by subsections (a), (b), and (c) of this section.
§ 360i. Records and reports on devices.
Every person who is a manufacturer, importer, or distributor of a device
intended for human use shall establish and maintain such records, make such
reports, and provide such information, as the Secretary may by regulation
reasonably require to assure that such device is not adulterated or misbranded
and to otherwise assure its safety and effectiveness. Regulations prescribed
under the preceding sentence -
- (1) shall require a device manufacturer or importer to report to the
Secretary whenever the manufacturer or importer receives or otherwise becomes
aware of information that reasonably suggests that one of its marketed devices -
- (A) may have caused or contributed to a death or serious injury, or
- (B) has malfunctioned and that such device or a similar device marketed by
the manufacturer or importer would be likely to cause or contribute to a death
or serious injury if the malfunction were to recur;
- (2) shall define the term ''serious injury'' to mean an injury that -
- (A) is life threatening,
- (B) results in permanent impairment of a body function or permanent damage
to a body structure, or
- (C) necessitates medical or surgical intervention to preclude permanent
impairment of a body function or permanent damage to a body structure;
- (3) shall require reporting of other significant adverse device experiences
as determined by the Secretary to be necessary to be reported;
- (4) shall not impose requirements unduly burdensome to a device
manufacturer, importer, or distributor taking into account his cost of complying
with such requirements and the need for the protection of the public health and
the implementation of this chapter;
- (5) which prescribe the procedure for making requests for reports or
information shall require that each request made under such regulations for
submission of a report or information to the Secretary state the reason or
purpose for such request and identify to the fullest extent practicable such
report or information;
- (6) which require submission of a report or information to the Secretary
shall state the reason or purpose for the submission of such report or
information and identify to the fullest extent practicable such report or
information;
- (7) may not require that the identity of any patient be disclosed in
records, reports, or information required under this subsection unless required
for the medical welfare of an individual, to determine the safety or
effectiveness of a device, or to verify a record, report, or information
submitted under this chapter;
- (8) may not require a manufacturer, importer, or distributor of a class I
device to -
- (A) maintain for such a device records respecting information not in the
possession of the manufacturer, importer, or distributor, or
- (B) to submit for such a device to the Secretary any report or information
-
- (i) not in the possession of the manufacturer, importer, or distributor, or
- (ii) on a periodic basis, unless such report or information is necessary to
determine if the device should be reclassified or if the device is adulterated
or misbranded; and
- (9) shall require distributors who submit such reports to submit copies of
the reports to the manufacturer of the device for which the report was made.
In prescribing such regulations, the Secretary shall have due regard for
the professional ethics of the medical profession and the interests of patients.
The prohibitions of paragraph (7) of this subsection continue to apply to
records, reports, and information concerning any individual who has been a
patient, irrespective of whether or when he ceases to be a patient.
- (b) User reports
- (1)
- (A) Whenever a device user facility receives or otherwise becomes aware of
information that reasonably suggests that a device has or may have caused or
contributed to the death of a patient of the facility, the facility shall, as
soon as practicable but not later than 10 working days after becoming aware of
the information, report the information to the Secretary and, if the identity of
the manufacturer is known, to the manufacturer of the device. In the case of
deaths, the Secretary may by regulation prescribe a shorter period for the
reporting of such information.
- (B) Whenever a device user facility receives or otherwise becomes aware of
-
- (i) information that reasonably suggests that a device has or may have
caused or contributed to the serious illness of, or serious injury to, a patient
of the facility, or
- (ii) other significant adverse device experiences as determined by the
Secretary by regulation to be necessary to be reported,
the
facility shall, as soon as practicable but not later than 10 working days after
becoming aware of the information, report the information to the manufacturer of
the device or to the Secretary if the identity of the manufacturer is not known.
- (C) Each device user facility shall submit to the Secretary on a
semi-annual basis a summary of the reports made under subparagraphs (A) and (B).
Such summary shall be submitted on January 1 and July 1 of each year. The
summary shall be in such form and contain such information from such reports as
the Secretary may require and shall include -
- (i) sufficient information to identify the facility which made the reports
for which the summary is submitted,
- (ii) in the case of any product which was the subject of a report, the
product name, serial number, and model number,
- (iii) the name and the address of the manufacturer of such device, and
- (iv) a brief description of the event reported to the manufacturer. The
Secretary may by regulation alter the frequency and timing of reports required
by this subparagraph.
- (D) For purposes of subparagraphs (A), (B), and (C), a device user facility
shall be treated as having received or otherwise become aware of information
with respect to a device of that facility when medical personnel who are
employed by or otherwise formally affiliated with the facility receive or
otherwise become aware of information with respect to that device in the course
of their duties.
- (2) The Secretary may not disclose the identity of a device user facility
which makes a report under paragraph (1) except in connection with -
- (A) an action brought to enforce section 331(q) of this title,
- (B) a communication to a manufacturer of a device which is the subject of a
report under paragraph (1), or
- (C) a disclosure required under subsection (a) of this section. This
paragraph does not prohibit the Secretary from disclosing the identity of a
device user facility making a report under paragraph (1) or any information in
such a report to employees of the Department of Health and Human Services, to
the Department of Justice, or to the duly authorized committees and
subcommittees of the Congress.
- (3) No report made under paragraph (1) by -
- (A) a device user facility,
- (B) an individual who is employed by or otherwise formally affiliated with
such a facility, or
- (C) a physician who is not required to make such a report, shall be
admissible into evidence or otherwise used in any civil action involving private
parties unless the facility, individual, or physician who made the report had
knowledge of the falsity of the information contained in the report.
- (4) A report made under paragraph (1) does not affect any obligation of a
manufacturer who receives the report to file a report as required under
subsection (a) of this section.
- (5) For purposes of this subsection:
- (A) The term ''device user facility'' means a hospital, ambulatory surgical
facility, nursing home, or outpatient treatment facility which is not a
physician's office. The Secretary may by regulation include an outpatient
diagnostic facility which is not a physician's office in such term.
- (B) The terms ''serious illness'' and ''serious injury'' mean illness or
injury, respectively, that -
- (i) is life threatening,
- (ii) results in permanent impairment of a body function or permanent damage
to a body structure, or
- (iii) necessitates medical or surgical intervention to preclude permanent
impairment of a body function or permanent damage to a body structure.
Subsection (a) of this section shall not apply to -
- (1) any practitioner who is licensed by law to prescribe or administer
devices intended for use in humans and who manufactures or imports devices
solely for use in the course of his professional practice;
- (2) any person who manufactures or imports devices intended for use in
humans solely for such person's use in research or teaching and not for sale
(including any person who uses a device under an exemption granted under section
360j(g) of this title); and
- (3) any other class of persons as the Secretary may by regulation exempt
from subsection (a) of this section upon a finding that compliance with the
requirements of such subsection by such class with respect to a device is not
necessary to (A) assure that a device is not adulterated or misbranded or (B)
otherwise to assure its safety and effectiveness.
Each manufacturer, importer, and distributor required to make reports under
subsection (a) of this section shall submit to the Secretary annually a
statement certifying that -
- (1) the manufacturer, importer, or distributor did file a certain
number of such reports, or
- (2) the manufacturer, importer, or distributor did not file any report
under subsection (a) of this section.
Every person who registers under section 360 of this title and is engaged in
the manufacture of -
- (1) a device the failure of which would be reasonably likely to have
serious adverse health consequences and which is (A) a permanently implantable
device, or (B) a life sustaining or life supporting device used outside a device
user facility, or
- (2) any other device which the Secretary may designate, shall adopt a
method of device tracking.
- (f) Reports of removals and corrections
- (1) Except as provided in paragraph (2), the Secretary shall by regulation
require a manufacturer, importer, or distributor of a device to report promptly
to the Secretary any correction or removal of a device undertaken by such
manufacturer, importer, or distributor if the removal or correction was
undertaken -
- (A) to reduce a risk to health posed by the device, or
- (B) to remedy a violation of this chapter caused by the device which may
present a risk to health.
A manufacturer, importer, or distributor
of a device who undertakes a correction or removal of a device which is not
required to be reported under this paragraph shall keep a record of such
correction or removal.
- (2) No report of the corrective action or removal of a device may be
required under paragraph (1) if a report of the corrective action or removal is
required and has been submitted under subsection (a) of this section.
- (3) For purposes of paragraphs (1) and (2), the terms ''correction'' and
''removal'' do not include routine servicing.
§ 360j. General provisions respecting control of devices intended
for human use.
Any requirement authorized by or under section 351, 352, 360, or 360i of
this title applicable to a device intended for human use shall apply to such
device until the applicability of the requirement to the device has been changed
by action taken under section 360c, 360d, or 360e of this title or under
subsection (g) of this section, and any requirement established by or under
section 351, 352, 360, or 360i of this title which is inconsistent with a
requirement imposed on such device under section 360d or 360e of this title or
under subsection (g) of this section shall not apply to such device.
Sections 360d and 360e of this title do not apply to any device which, in
order to comply with the order of an individual physician or dentist (or any
other specially qualified person designated under regulations promulgated by the
Secretary after an opportunity for an oral hearing) necessarily deviates from an
otherwise applicable performance standard or requirement prescribed by or under
section 360e of this title if
- (1) the device is not generally available in finished form for
purchase or for dispensing upon prescription and is not offered through labeling
or advertising by the manufacturer, importer, or distributor thereof for
commercial distribution, and
- (2) such device -
- (A)
- (i) is intended for use by an individual patient named in such order of
such physician or dentist (or other specially qualified person so designated)
and is to be made in a specific form for such patient, or
- (ii) is intended to meet the special needs of such physician or dentist (or
other specially qualified person so designated) in the course of the
professional practice of such physician or dentist (or other specially qualified
person so designated), and
- (B) is not generally available to or generally used by other physicians or
dentists (or other specially qualified persons so designated).
Any information reported to or otherwise obtained by the Secretary or his
representative under section 360c, 360d, 360e, 360f, 360h, 360i, or 374 of this
title or under subsection (f) or (g) of this section which is exempt from
disclosure pursuant to subsection (a) of section 552 of title 5 by reason of
subsection (b)(4) of such section shall be considered confidential and shall not
be disclosed and may not be used by the Secretary as the basis for the
reclassification of a device from class III to class II or class I or as the
basis for the establishment or amendment of a performance standard under section
360d of this title for a device reclassified from class III to class II, except
(1) in accordance with subsection (h) of this section, and (2) that such
information may be disclosed to other officers or employees concerned with
carrying out this chapter or when relevant in any proceeding under this chapter
(other than section 360c or 360d of this title).
Each notice of proposed rulemaking under section 360c, 360d, 360e, 360f,
360h, or 360i of this title, or under this section, any other notice which is
published in the Federal Register with respect to any other action taken under
any such section and which states the reasons for such action, and each
publication of findings required to be made in connection with rulemaking under
any such section shall set forth -
- (1) the manner in which interested persons may examine data and other
information on which the notice or findings is based, and
- (2) the period within which interested persons may present their comments
on the notice or findings (including the need therefor) orally or in writing,
which period shall be at least sixty days but may not exceed ninety days unless
the time is extended by the Secretary by a notice published in the Federal
Register stating good cause therefor.
- (e) Restricted devices
- (1) The Secretary may by regulation require that a device be restricted to
sale, distribution, or use -
- (A) only upon the written or oral authorization of a practitioner licensed
by law to administer or use such device, or
- (B) upon such other conditions as the Secretary may prescribe in such
regulation,
if, because of its potentiality for harmful effect or
the collateral measures necessary to its use, the Secretary determines that
there cannot otherwise be reasonable assurance of its safety and effectiveness.
No condition prescribed under subparagraph (B) may restrict the use of a device
to persons with specific training or experience in its use or to persons for use
in certain facilities unless the Secretary determines that such a restriction is
required for the safe and effective use of the device. No such condition may
exclude a person from using a device solely because the person does not have the
training or experience to make him eligible for certification by a certifying
board recognized by the American Board of Medical Specialties or has not been
certified by such a Board. A device subject to a regulation under this
subsection is a restricted device.
- (2) The label of a restricted device shall bear such appropriate statements
of the restrictions required by a regulation under paragraph (1) as the
Secretary may in such regulation prescribe.
- (f) Good manufacturing practice requirements
- (1)
- (A) The Secretary may, in accordance with subparagraph (B), prescribe
regulations requiring that the methods used in, and the facilities and controls
used for, the manufacture, pre-production design validation (including a process
to assess the performance of a device but not including an evaluation of the
safety or effectiveness of a device), packing, storage, and installation of a
device conform to current good manufacturing practice, as prescribed in such
regulations, to assure that the device will be safe and effective and otherwise
in compliance with this chapter.
- (B) Before the Secretary may promulgate any regulation under subparagraph
(A) he shall -
- (i) afford the advisory committee established under paragraph (3) an
opportunity to submit recommendations to him with respect to the regulation
proposed to be promulgated, and
- (ii) afford opportunity for an oral hearing. The Secretary shall provide
the advisory committee a reasonable time to make its recommendation with respect
to proposed regulations under subparagraph (A).
- (2)
- (A) Any person subject to any requirement prescribed by regulations under
paragraph (1) may petition the Secretary for an exemption or variance from such
requirement. Such a petition shall be submitted to the Secretary in such form
and manner as he shall prescribe and shall -
- (i) in the case of a petition for an exemption from a requirement, set
forth the basis for the petitioner's determination that compliance with the
requirement is not required to assure that the device will be safe and effective
and otherwise in compliance with this chapter,
- (ii) in the case of a petition for a variance from a requirement, set forth
the methods proposed to be used in, and the facilities and controls proposed to
be used for, the manufacture, packing, storage, and installation of the device
in lieu of the methods, facilities, and controls prescribed by the requirement,
and
- (iii) contain such other information as the Secretary shall prescribe.
- (B) The Secretary may refer to the advisory committee established under
paragraph (3) any petition submitted under subparagraph (A). The advisory
committee shall report its recommendations to the Secretary with respect to a
petition referred to it within sixty days of the date of the petition's
referral. Within sixty days after -
- (i) the date the petition was submitted to the Secretary under subparagraph
(A), or
- (ii) if the petition was referred to an advisory committee, the expiration
of the sixty-day period beginning on the date the petition was referred to the
advisory committee, whichever occurs later, the Secretary shall by order either
deny the petition or approve it.
- (C) The Secretary may approve -
- (i) a petition for an exemption for a device from a requirement if he
determines that compliance with such requirement is not required to assure that
the device will be safe and effective and otherwise in compliance with this
chapter, and
- (ii) a petition for a variance for a device from a requirement if he
determines that the methods to be used in, and the facilities and controls to be
used for, the manufacture, packing, storage, and installation of the device in
lieu of the methods, controls, and facilities prescribed by the requirement are
sufficient to assure that the device will be safe and effective and otherwise in
compliance with this chapter.
An order of the Secretary approving
a petition for a variance shall prescribe such conditions respecting the methods
used in, and the facilities and controls used for, the manufacture, packing,
storage, and installation of the device to be granted the variance under the
petition as may be necessary to assure that the device will be safe and
effective and otherwise in compliance with this chapter.
- (D) After the issuance of an order under subparagraph (B) respecting a
petition, the petitioner shall have an opportunity for an informal hearing on
such order.
- (3) The Secretary shall establish an advisory committee for the purpose of
advising and making recommendations to him with respect to regulations proposed
to be promulgated under paragraph (1)(A) and the approval or disapproval of
petitions submitted under paragraph (2). The advisory committee shall be
composed of nine members as follows:
- (A) Three of the members shall be appointed from persons who are officers
or employees of any State or local government or of the Federal Government.
- (B) Two of the members shall be appointed from persons who are
representative of interests of the device manufacturing industry; two of the
members shall be appointed from persons who are representative of the interests
of physicians and other health professionals; and two of the members shall be
representative of the interests of the general public.
Members of
the advisory committee who are not officers or employees of the United States,
while attending conferences or meetings of the committee or otherwise engaged in
its business, shall be entitled to receive compensation at rates to be fixed by
the Secretary, which rates may not exceed the daily equivalent of the rate in
effect for grade GS-18 of the General Schedule, for each day (including
traveltime) they are so engaged; and while so serving away from their homes or
regular places of business each member may be allowed travel expenses, including
per diem in lieu of subsistence, as authorized by section 5703 of title 5 for
persons in the Government service employed intermittently. The Secretary shall
designate one of the members of the advisory committee to serve as its chairman.
The Secretary shall furnish the advisory committee with clerical and other
assistance. Section 14 of the Federal Advisory Committee Act shall not apply
with respect to the duration of the advisory committee established under this
paragraph.
- (g) Exemption for devices for investigational use
- (h) Release of information respecting safety and effectiveness
- (i) Proceedings of advisory panels and committees
Each panel under section 360c of this title and each advisory committee
established under section 360d(b)(5)(B) or 360e(g) of this title or under
subsection (f) of this section shall make and maintain a transcript of any
proceeding of the panel or committee. Each such panel and committee shall delete
from any transcript made pursuant to this subsection information which under
subsection (c) of this section is to be considered confidential.
Except as provided in section 360i(e) of this title, no regulation under
this chapter may impose on a type or class of device requirements for the
traceability of such type or class of device unless such requirements are
necessary to assure the protection of the public health.
- (k) Research and development
The Secretary may enter into contracts for research, testing, and
demonstrations respecting devices and may obtain devices for research, testing,
and demonstration purposes without regard to section 3324(a) and (b) of title 31
and section 5 of title 41.
- (l) Transitional provisions for devices considered as new drugs or
antibiotic drugs
- (m) Humanitarian device exemption
- (1) To the extent consistent with the protection of the public health and
safety and with ethical standards, it is the purpose of this subsection to
encourage the discovery and use of devices intended to benefit patients in the
treatment and diagnosis of diseases or conditions that affect fewer than 4,000
individuals in the United States.
- (2) The Secretary may grant a request for an exemption from the
effectiveness requirements of sections 360d and 360e of this title for a device
for which the Secretary finds that -
- (A) the device is designed to treat or diagnose a disease or condition that
affects fewer than 4,000 individuals in the United States,
- (B) the device would not be available to a person with a disease or
condition referred to in subparagraph (A) unless the Secretary grants such an
exemption and there is no comparable device, other than under this exemption,
available to treat or diagnose such disease or condition, and
- (C) the device will not expose patients to an unreasonable or significant
risk of illness or injury and the probable benefit to health from the use of the
device outweighs the risk of injury or illness from its use, taking into account
the probable risks and benefits of currently available devices or alternative
forms of treatment.
- (3) No person granted an exemption under paragraph (2) with respect to a
device may sell the device for an amount that exceeds the costs of research and
development, fabrication, and distribution of the device.
- (4) Devices granted an exemption under paragraph (2) may only be used -
- (A) in facilities that have established, in accordance with regulations of
the Secretary, a local institutional review committee to supervise clinical
testing of devices in the facilities, and
- (B) if, before the use of a device, an institutional review committee
approves the use in the treatment or diagnosis of a disease or condition
referred to in paragraph (2)(A).
- (5) An exemption under paragraph (2) shall be for a term of 18 months and
may only be initially granted in the 5-year period beginning on the date
regulations under paragraph (6) take effect. The Secretary may extend such an
exemption for a period of 18 months if the Secretary is able to make the
findings set forth in paragraph (2) and if the applicant supplies information
demonstrating compliance with paragraph (3). An exemption may be extended more
than once and may be extended after the expiration of such 5-year period.
- (6) Within one year of November 28, 1990, the Secretary shall issue
regulations to implement this subsection.
§ 360k. State and local requirements respecting devices.
Except as provided in subsection (b) of this section, no State or political
subdivision of a State may establish or continue in effect with respect to a
device intended for human use any requirement -
- (1) which is different from, or in addition to, any requirement
applicable under this chapter to the device, and
- (2) which relates to the safety or effectiveness of the device or to any
other matter included in a requirement applicable to the device under this
chapter.
Upon application of a State or a political subdivision thereof, the
Secretary may, by regulation promulgated after notice and opportunity for an
oral hearing, exempt from subsection (a) of this section, under such conditions
as may be prescribed in such regulation, a requirement of such State or
political subdivision applicable to a device intended for human use if -
- (1) the requirement is more stringent than a requirement under this
chapter which would be applicable to the device if an exemption were not in
effect under this subsection; or
- (2) the requirement -
- (A) is required by compelling local conditions, and
- (B) compliance with the requirement would not cause the device to be in
violation of any applicable requirement under this chapter.
§ 360l. Postmarket surveillance.
- (a) In general
- (1) Required surveillance The Secretary shall require a
manufacturer to conduct postmarket surveillance for any device of the
manufacturer first introduced or delivered for introduction into interstate
commerce after January 1, 1991, that -
- (A) is a permanent implant the failure of which may cause serious, adverse
health consequences or death,
- (B) is intended for a use in supporting or sustaining human life, or
- (C) potentially presents a serious risk to human health.
- (2) Discretionary surveillance The Secretary may require a
manufacturer to conduct postmarket surveillance for a device of the manufacturer
if the Secretary determines that postmarket surveillance of the device is
necessary to protect the public health or to provide safety or effectiveness
data for the device.
- (b) Surveillance approval
Each manufacturer required to conduct a surveillance of a device under
subsection (a)(1) of this section shall, within 30 days of the first
introduction or delivery for introduction of such device into interstate
commerce, submit, for the approval of the Secretary, a protocol for the required
surveillance. Each manufacturer required to conduct a surveillance of a device
under subsection (a)(2) of this section shall, within 30 days after receiving
notice that the manufacturer is required to conduct such surveillance, submit,
for the approval of the Secretary, a protocol for the required surveillance. The
Secretary, within 60 days of the receipt of such protocol, shall determine if
the principal investigator proposed to be used in the surveillance has
sufficient qualifications and experience to conduct such surveillance and if
such protocol will result in collection of useful data or other information
necessary to protect the public health and to provide safety and effectiveness
information for the device. The Secretary may not approve such a protocol until
it has been reviewed by an appropriately qualified scientific and technical
review committee established by the Secretary.
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