
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360j]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 360j. General provisions respecting control of devices 
        intended for human use
        

(a) General rule

    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.

(b) Custom devices

    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).

(c) Trade secrets

    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).

(d) Notices and findings

    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;
        (ii) afford opportunity for an oral hearing; and
        (iii) ensure that such regulation conforms, to the extent 
    practicable, with internationally recognized standards defining 
    quality systems, or parts of the standards, for medical devices.

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

    (1) It is the purpose of this subsection to encourage, to the extent 
consistent with the protection of the public health and safety and with 
ethical standards, the discovery and development of useful devices 
intended for human use and to that end to maintain optimum freedom for 
scientific investigators in their pursuit of that purpose.
    (2)(A) The Secretary shall, within the one hundred and twenty-day 
period beginning on May 28, 1976, by regulation prescribe procedures and 
conditions under which devices intended for human use may upon 
application be granted an exemption from the requirements of section 
352, 360, 360d, 360e, 360f, 360i, or 379e of this title or subsection 
(e) or (f) of this section or from any combination of such requirements 
to permit the investigational use of such devices by experts qualified 
by scientific training and experience to investigate the safety and 
effectiveness of such devices.
    (B) The conditions prescribed pursuant to subparagraph (A) shall 
include the following:
        (i) A requirement that an application be submitted to the 
    Secretary before an exemption may be granted and that the 
    application be submitted in such form and manner as the Secretary 
    shall specify.
        (ii) A requirement that the person applying for an exemption for 
    a device assure the establishment and maintenance of such records, 
    and the making of such reports to the Secretary of data obtained as 
    a result of the investigational use of the device during the 
    exemption, as the Secretary determines will enable him to assure 
    compliance with such conditions, review the progress of the 
    investigation, and evaluate the safety and effectiveness of the 
    device.
        (iii) Such other requirements as the Secretary may determine to 
    be necessary for the protection of the public health and safety.

    (C) Procedures and conditions prescribed pursuant to subparagraph 
(A) for an exemption may appropriately vary depending on (i) the scope 
and duration of clinical testing to be conducted under such exemption, 
(ii) the number of human subjects that are to be involved in such 
testing, (iii) the need to permit changes to be made in the device 
subject to the exemption during testing conducted in accordance with a 
clinical testing plan required under paragraph (3)(A), and (iv) whether 
the clinical testing of such device is for the purpose of developing 
data to obtain approval for the commercial distribution of such device.
    (3) Procedures and conditions prescribed pursuant to paragraph 
(2)(A) shall require, as a condition to the exemption of any device to 
be the subject of testing involving human subjects, that the person 
applying for the exemption--
        (A) submit a plan for any proposed clinical testing of the 
    device and a report of prior investigations of the device 
    (including, where appropriate, tests on animals) adequate to justify 
    the proposed clinical testing--
            (i) to the local institutional review committee which has 
        been established in accordance with regulations of the Secretary 
        to supervise clinical testing of devices in the facilities where 
        the proposed clinical testing is to be conducted, or
            (ii) to the Secretary, if--
                (I) no such committee exists, or
                (II) the Secretary finds that the process of review by 
            such committee is inadequate (whether or not the plan for 
            such testing has been approved by such committee),

        for review for adequacy to justify the commencement of such 
        testing; and, unless the plan and report are submitted to the 
        Secretary, submit to the Secretary a summary of the plan and a 
        report of prior investigations of the device (including, where 
        appropriate, tests on animals);

        (B) promptly notify the Secretary (under such circumstances and 
    in such manner as the Secretary prescribes) of approval by a local 
    institutional review committee of any clinical testing plan 
    submitted to it in accordance with subparagraph (A);
        (C) in the case of a device to be distributed to investigators 
    for testing, obtain signed agreements from each of such 
    investigators that any testing of the device involving human 
    subjects will be under such investigator's supervision and in 
    accordance with subparagraph (D) and submit such agreements to the 
    Secretary; and
        (D) assure that informed consent will be obtained from each 
    human subject (or his representative) of proposed clinical testing 
    involving such device, except where subject to such conditions as 
    the Secretary may prescribe, the investigator conducting or 
    supervising the proposed clinical testing of the device determines 
    in writing that there exists a life threatening situation involving 
    the human subject of such testing which necessitates the use of such 
    device and it is not feasible to obtain informed consent from the 
    subject and there is not sufficient time to obtain such consent from 
    his representative.

The determination required by subparagraph (D) shall be concurred in by 
a licensed physician who is not involved in the testing of the human 
subject with respect to which such determination is made unless 
immediate use of the device is required to save the life of the human 
subject of such testing and there is not sufficient time to obtain such 
concurrence.
    (4)(A) An application, submitted in accordance with the procedures 
prescribed by regulations under paragraph (2), for an exemption for a 
device (other than an exemption from section 360f of this title) shall 
be deemed approved on the thirtieth day after the submission of the 
application to the Secretary unless on or before such day the Secretary 
by order disapproves the application and notifies the applicant of the 
disapproval of the application.
    (B) The Secretary may disapprove an application only if he finds 
that the investigation with respect to which the application is 
submitted does not conform to procedures and conditions prescribed under 
regulations under paragraph (2). Such a notification shall contain the 
order of disapproval and a complete statement of the reasons for the 
Secretary's disapproval of the application and afford the applicant 
opportunity for an informal hearing on the disapproval order.
    (5) The Secretary may by order withdraw an exemption granted under 
this subsection for a device if the Secretary determines that the 
conditions applicable to the device under this subsection for such 
exemption are not met. Such an order may be issued only after 
opportunity for an informal hearing, except that such an order may be 
issued before the provision of an opportunity for an informal hearing if 
the Secretary determines that the continuation of testing under the 
exemption with respect to which the order is to be issued will result in 
an unreasonable risk to the public health.
    (6)(A) Not later than 1 year after November 21, 1997, the Secretary 
shall by regulation establish, with respect to a device for which an 
exemption under this subsection is in effect, procedures and conditions 
that, without requiring an additional approval of an application for an 
exemption or the approval of a supplement to such an application, 
permit--
        (i) developmental changes in the device (including manufacturing 
    changes) that do not constitute a significant change in design or in 
    basic principles of operation and that are made in response to 
    information gathered during the course of an investigation; and
        (ii) changes or modifications to clinical protocols that do not 
    affect--
            (I) the validity of data or information resulting from the 
        completion of an approved protocol, or the relationship of 
        likely patient risk to benefit relied upon to approve a 
        protocol;
            (II) the scientific soundness of an investigational plan 
        submitted under paragraph (3)(A); or
            (III) the rights, safety, or welfare of the human subjects 
        involved in the investigation.

    (B) Regulations under subparagraph (A) shall provide that a change 
or modification described in such subparagraph may be made if--
        (i) the sponsor of the investigation determines, on the basis of 
    credible information (as defined by the Secretary) that the 
    applicable conditions under subparagraph (A) are met; and
        (ii) the sponsor submits to the Secretary, not later than 5 days 
    after making the change or modification, a notice of the change or 
    modification.

    (7)(A) In the case of a person intending to investigate the safety 
or effectiveness of a class III device or any implantable device, the 
Secretary shall ensure that the person has an opportunity, prior to 
submitting an application to the Secretary or to an institutional review 
committee, to submit to the Secretary, for review, an investigational 
plan (including a clinical protocol). If the applicant submits a written 
request for a meeting with the Secretary regarding such review, the 
Secretary shall, not later than 30 days after receiving the request, 
meet with the applicant for the purpose of reaching agreement regarding 
the investigational plan (including a clinical protocol). The written 
request shall include a detailed description of the device, a detailed 
description of the proposed conditions of use of the device, a proposed 
plan (including a clinical protocol) for determining whether there is a 
reasonable assurance of effectiveness, and, if available, information 
regarding the expected performance from the device.
    (B) Any agreement regarding the parameters of an investigational 
plan (including a clinical protocol) that is reached between the 
Secretary and a sponsor or applicant shall be reduced to writing and 
made part of the administrative record by the Secretary. Any such 
agreement shall not be changed, except--
        (i) with the written agreement of the sponsor or applicant; or
        (ii) pursuant to a decision, made in accordance with 
    subparagraph (C) by the director of the office in which the device 
    involved is reviewed, that a substantial scientific issue essential 
    to determining the safety or effectiveness of the device involved 
    has been identified.

    (C) A decision under subparagraph (B)(ii) by the director shall be 
in writing, and may be made only after the Secretary has provided to the 
sponsor or applicant an opportunity for a meeting at which the director 
and the sponsor or applicant are present and at which the director 
documents the scientific issue involved.

(h) Release of information respecting safety and effectiveness

    (1) The Secretary shall promulgate regulations under which a 
detailed summary of information respecting the safety and effectiveness 
of a device which information was submitted to the Secretary and which 
was the basis for--
        (A) an order under section 360e(d)(1)(A) of this title approving 
    an application for premarket approval for the device or denying 
    approval of such an application or an order under section 360e(e) of 
    this title withdrawing approval of such an application for the 
    device,
        (B) an order under section 360e(f)(6)(A) of this title revoking 
    an approved protocol for the device, an order under section 
    360e(f)(6)(B) of this title declaring a protocol for the device 
    completed or not completed, or an order under section 360e(f)(7) of 
    this title revoking the approval of the device, or
        (C) an order approving an application under subsection (g) of 
    this section for an exemption for the device from section 360f of 
    this title or an order disapproving, or withdrawing approval of, an 
    application for an exemption under such subsection for the device,

shall be made available to the public upon issuance of the order. 
Summaries of information made available pursuant to this paragraph 
respecting a device shall include information respecting any adverse 
effects on health of the device.
    (2) The Secretary shall promulgate regulations under which each 
advisory committee established under section 360e(g)(2)(B) of this title 
shall make available to the public a detailed summary of information 
respecting the safety and effectiveness of a device which information 
was submitted to the advisory committee and which was the basis for its 
recommendation to the Secretary made pursuant to section 360e(g)(2)(A) 
of this title. A summary of information upon which such a recommendation 
is based shall be made available pursuant to this paragraph only after 
the issuance of the order with respect to which the recommendation was 
made and each summary shall include information respecting any adverse 
effect on health of the device subject to such order.
    (3) Except as provided in paragraph (4), any information respecting 
a device which is made available pursuant to paragraph (1) or (2) of 
this subsection (A) may not be used to establish the safety or 
effectiveness of another device for purposes of this chapter by any 
person other than the person who submitted the information so made 
available, and (B) shall be made available subject to subsection (c) of 
this section.
    (4)(A) Any information contained in an application for premarket 
approval filed with the Secretary pursuant to section 360e(c) of this 
title (including information from clinical and preclinical tests or 
studies that demonstrate the safety and effectiveness of a device, but 
excluding descriptions of methods of manufacture and product composition 
and other trade secrets) shall be available, 6 years after the 
application has been approved by the Secretary, for use by the Secretary 
in--
        (i) approving another device;
        (ii) determining whether a product development protocol has been 
    completed, under section 360e of this title for another device;
        (iii) establishing a performance standard or special control 
    under this chapter; or
        (iv) classifying or reclassifying another device under section 
    360c of this title and subsection (l)(2) of this section.

    (B) The publicly available detailed summaries of information 
respecting the safety and effectiveness of devices required by paragraph 
(1)(A) shall be available for use by the Secretary as the evidentiary 
basis for the agency actions described in subparagraph (A).

(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.

(j) Traceability

    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

    (1) Any device intended for human use--
        (A) for which on May 28, 1976 (hereinafter in this subsection 
    referred to as the ``enactment date'') an approval of an application 
    submitted under section 355(b) of this title was in effect;
        (B) for which such an application was filed on or before the 
    enactment date and with respect to which application no order of 
    approval or refusing to approve had been issued on such date under 
    subsection (c) or (d) of such section;
        (C) for which on the enactment date an exemption under 
    subsection (i) of such section was in effect;
        (D) which is within a type of device described in subparagraph 
    (A), (B), or (C) and is substantially equivalent to another device 
    within that type;
        (E) which the Secretary in a notice published in the Federal 
    Register before the enactment date has declared to be a new drug 
    subject to section 355 of this title; or
        (F) with respect to which on the enactment date an action is 
    pending in a United States court under section 332, 333, or 334 of 
    this title for an alleged violation of a provision of section 331 of 
    this title which enforces a requirement of section 355 of this title 
    or for an alleged violation of section 355(a) of this title,

is classified in class III unless the Secretary in response to a 
petition submitted under paragraph (2) has classified such device in 
class I or II.
    (2) The Secretary may initiate the reclassification of a device 
classified into class III under paragraph (1) of this subsection or the 
manufacturer or importer of a device classified under paragraph (1) may 
petition the Secretary (in such form and manner as he shall prescribe) 
for the issuance of an order classifying the device in class I or class 
II. Within thirty days of the filing of such a petition, the Secretary 
shall notify the petitioner of any deficiencies in the petition which 
prevent the Secretary from making a decision on the petition. Except as 
provided in paragraph (3)(D)(ii), within one hundred and eighty days 
after the filing of a petition under this paragraph, the Secretary 
shall, after consultation with the appropriate panel under section 360c 
of this title, by order either deny the petition or order the 
classification, in accordance with the criteria prescribed by section 
360c(a)(1)(A) of this title or 360c(a)(1)(B) of this title, of the 
device in class I or class II.
    (3)(A) In the case of a device which is described in paragraph 
(1)(A) and which is in class III--
        (i) such device shall on the enactment date be considered a 
    device with an approved application under section 360e of this 
    title, and
        (ii) the requirements applicable to such device before the 
    enactment date under section 355 of this title shall continue to 
    apply to such device until changed by the Secretary as authorized by 
    this chapter.

    (B) In the case of a device which is described in paragraph (1)(B) 
and which is in class III, an application for such device shall be 
considered as having been filed under section 360e of this title on the 
enactment date. The period in which the Secretary shall act on such 
application in accordance with section 360e(d)(1) of this title shall be 
one hundred and eighty days from the enactment date (or such greater 
period as the Secretary and the applicant may agree upon after the 
Secretary has made the finding required by section 360e(d)(1)(B)(i) of 
this title) less the number of days in the period beginning on the date 
an application for such device was filed under section 355 of this title 
and ending on the enactment date. After the expiration of such period 
such device is required, unless exempt under subsection (g) of this 
section, to have in effect an approved application under section 360e of 
this title.
    (C) A device which is described in paragraph (1)(C) and which is in 
class III shall be considered a new drug until the expiration of the 
ninety-day period beginning on the date of the promulgation of 
regulations under subsection (g) of this section. After the expiration 
of such period such device is required, unless exempt under subsection 
(g) of this section, to have in effect an approved application under 
section 360e of this title.
    (D)(i) Except as provided in clauses (ii) and (iii), a device which 
is described in subparagraph (D), (E), or (F) of paragraph (1) and which 
is in class III is required, unless exempt under subsection (g) of this 
section, to have on and after sixty days after the enactment date in 
effect an approved application under section 360e of this title.
    (ii) If--
        (I) a petition is filed under paragraph (2) for a device 
    described in subparagraph (D), (E), or (F) of paragraph (1), or
        (II) an application for premarket approval is filed under 
    section 360e of this title for such a device,

within the sixty-day period beginning on the enactment date (or within 
such greater period as the Secretary, after making the finding required 
under section 360e(d)(1)(B) of this title, and the petitioner or 
applicant may agree upon), the Secretary shall act on such petition or 
application in accordance with paragraph (2) or section 360e of this 
title except that the period within which the Secretary must act on the 
petition or application shall be within the one hundred and twenty-day 
period beginning on the date the petition or application is filed. If 
such a petition or application is filed within such sixty-day (or 
greater) period, clause (i) of this subparagraph shall not apply to such 
device before the expiration of such one hundred and twenty-day period, 
or if such petition is denied or such application is denied approval, 
before the date of such denial, whichever occurs first.
    (iii) In the case of a device which is described in subparagraph (E) 
of paragraph (1), which the Secretary in a notice published in the 
Federal Register after March 31, 1976, declared to be a new drug subject 
to section 355 of this title, and which is in class III--
        (I) the device shall, after eighteen months after the enactment 
    date, have in effect an approved application under section 360e of 
    this title unless exempt under subsection (g) of this section, and
        (II) the Secretary may, during the period beginning one hundred 
    and eighty days after the enactment date and ending eighteen months 
    after such date, restrict the use of the device to investigational 
    use by experts qualified by scientific training and experience to 
    investigate the safety and effectiveness of such device, and to 
    investigational use in accordance with the requirements applicable 
    under regulations under subsection (g) of this section to 
    investigational use of devices granted an exemption under such 
    subsection.

If the requirements under subsection (g) of this section are made 
applicable to the investigational use of such a device, they shall be 
made applicable in such a manner that the device shall be made 
reasonably available to physicians meeting appropriate qualifications 
prescribed by the Secretary.
    (4) Repealed. Pub. L. 105-115, title I, Sec. 125(b)(2)(E), Nov. 21, 
1997, 111 Stat. 2325.
    (5)(A) Before December 1, 1991, the Secretary shall by order require 
manufacturers of devices described in paragraph (1), which are subject 
to revision of classification under subparagraph (B), to submit to the 
Secretary a summary of and citation to any information known or 
otherwise available to the manufacturers respecting the devices, 
including adverse safety or effectiveness information which has not been 
submitted under section 360i of this title. The Secretary may require a 
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.
    (B) Except as provided in subparagraph (C), after the issuance of an 
order under subparagraph (A) but before December 1, 1992, the Secretary 
shall publish a regulation in the Federal Register for each device which 
is classified in class III under paragraph (1) 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 
subparagraph and provide an opportunity for the submission of comments 
on any such regulation. No regulation under this subparagraph 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 the publication 
in the Federal Register of the proposed regulation.
    (C) The Secretary may by notice published in the Federal Register 
extend the period prescribed by subparagraph (B) for a device for an 
additional period not to exceed 1 year.

(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.

The request shall be in the form of an application submitted to the 
Secretary. Not later than 75 days after the date of the receipt of the 
application, the Secretary shall issue an order approving or denying the 
application.
    (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), unless a 
    physician determines in an emergency situation that approval from a 
    local institutional review committee can not be obtained in time to 
    prevent serious harm or death to a patient.

In a case described in subparagraph (B) in which a physician uses a 
device without an approval from an institutional review committee, the 
physician shall, after the use of the device, notify the chairperson of 
the local institutional review committee of such use. Such notification 
shall include the identification of the patient involved, the date on 
which the device was used, and the reason for the use.
    (5) The Secretary may require a person granted an exemption under 
paragraph (2) to demonstrate continued compliance with the requirements 
of this subsection if the Secretary believes such demonstration to be 
necessary to protect the public health or if the Secretary has reason to 
believe that the criteria for the exemption are no longer met.
    (6) The Secretary may suspend or withdraw an exemption from the 
effectiveness requirements of sections 360d and 360e of this title for a 
humanitarian device only after providing notice and an opportunity for 
an informal hearing.

(June 25, 1938, ch. 675, Sec. 520, as added Pub. L. 94-295, Sec. 2, May 
28, 1976, 90 Stat. 565; amended Pub. L. 101-629, Secs. 3(b)(2), 4(b)(2), 
5(c)(2), 6(b)(2), 11, 14(a), 18(e), (f), Nov. 28, 1990, 104 Stat. 4514, 
4516, 4518, 4519, 4522, 4524, 4529; Pub. L. 102-571, title I, 
Sec. 107(10), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 105-115, title I, 
Sec. 125(b)(2)(E), title II, Secs. 201(a), 203, 216(a)(1), title IV, 
Sec. 410(a), Nov. 21, 1997, 111 Stat. 2325, 2332, 2334, 2349, 2372.)

                       References in Text

    Section 14 of the Federal Advisory Committee Act, referred to in 
subsec. (f)(3), is section 14 of Pub. L. 92-463, which is set out in the 
Appendix to Title 5, Government Organization and Employees.

                          Codification

    In subsec. (k), ``section 3324(a) and (b) of title 31'' substituted 
for reference to section 3648 of the Revised Statutes (31 U.S.C. 529) on 
authority of Pub. L. 97-258, Sec. 4(b), Sept. 13, 1982, 96 Stat. 1067, 
the first section of which enacted Title 31, Money and Finance.


                               Amendments

    1997--Subsec. (f)(1)(B)(iii). Pub. L. 105-115, Sec. 410(a), added 
cl. (iii).
    Subsec. (g)(6), (7). Pub. L. 105-115, Sec. 201(a), added pars. (6) 
and (7).
    Subsec. (h)(4). Pub. L. 105-115, Sec. 216(a)(1), amended par. (4) 
generally. Prior to amendment, par. (4) related to premarket approval of 
devices.
    Subsec. (l). Pub. L. 105-115, Sec. 125(b)(2)(E), struck out ``or 
antibiotic drugs'' after ``new drugs'' in heading.
    Subsec. (l)(4). Pub. L. 105-115, Sec. 125(b)(2)(E), struck out par. 
(4) which read as follows: ``Any device intended for human use which on 
the enactment date was subject to the requirements of section 357 of 
this title shall be subject to such requirements as follows:
        ``(A) In the case of such a device which is classified into 
    class I, such requirements shall apply to such device until the 
    effective date of the regulation classifying the device into such 
    class.
        ``(B) In the case of such a device which is classified into 
    class II, such requirements shall apply to such device until the 
    effective date of a performance standard applicable to the device 
    under section 360d of this title.
        ``(C) In the case of such a device which is classified into 
    class III, such requirements shall apply to such device until the 
    date on which the device is required to have in effect an approved 
    application under section 360e of this title.''
    Subsec. (m)(2). Pub. L. 105-115, Sec. 203(1), inserted at end ``The 
request shall be in the form of an application submitted to the 
Secretary. Not later than 75 days after the date of the receipt of the 
application, the Secretary shall issue an order approving or denying the 
application.''
    Subsec. (m)(4). Pub. L. 105-115, Sec. 203(2)(B), inserted at end 
``In a case described in subparagraph (B) in which a physician uses a 
device without an approval from an institutional review committee, the 
physician shall, after the use of the device, notify the chairperson of 
the local institutional review committee of such use. Such notification 
shall include the identification of the patient involved, the date on 
which the device was used, and the reason for the use.''
    Subsec. (m)(4)(B). Pub. L. 105-115, Sec. 203(2)(A), inserted before 
period at end ``, unless a physician determines in an emergency 
situation that approval from a local institutional review committee can 
not be obtained in time to prevent serious harm or death to a patient''.
    Subsec. (m)(5). Pub. L. 105-115, Sec. 203(3), amended par. (5) 
generally. Prior to amendment, par. (5) read as follows: ``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.''
    Subsec. (m)(6). Pub. L. 105-115, Sec. 203(4), amended par. (6) 
generally. Prior to amendment, par. (6) read as follows: ``Within one 
year of November 28, 1990, the Secretary shall issue regulations to 
implement this subsection.''
    1992--Subsec. (g)(2)(A). Pub. L. 102-571 substituted ``379e'' for 
``376''.
    1990--Subsec. (c). Pub. L. 101-629, Sec. 11(1), substituted ``from 
class III to class II or class I'' for ``under section 360c of this 
title from class III to class II'' and inserted ``(1) in accordance with 
subsection (h) of this section, and (2)'' after ``except''.
    Subsec. (f)(1)(A). Pub. L. 101-629, Sec. 18(e), inserted ``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),'' after ``manufacture,''.
    Subsec. (h)(3). Pub. L. 101-629, Sec. 11(2)(A), substituted ``Except 
as provided in paragraph (4), any'' for ``Any''.
    Subsec. (h)(4). Pub. L. 101-629, Sec. 11(2)(B), added par. (4).
    Subsec. (i). Pub. L. 101-629, Sec. 6(b)(2), substituted ``section 
360d(b)(5)(B)'' for ``section 360d(g)(5)(B)''.
    Subsec. (j). Pub. L. 101-629, Sec. 3(b)(2), substituted ``Except as 
provided in section 360i(e) of this title, no'' for ``No''.
    Subsec. (l)(2). Pub. L. 101-629, Sec. 18(f), struck out ``and after 
affording the petitioner an opportunity for an informal hearing'' after 
``under this paragraph''.
    Pub. L. 101-629, Sec. 5(c)(2), substituted ``The Secretary may 
initiate the reclassification of a device classified into class III 
under paragraph (1) of this subsection or the manufacturer'' for ``The 
manufacturer''.
    Subsec. (l)(5). Pub. L. 101-629, Sec. 4(b)(2), added par. (5).
    Subsec. (m). Pub. L. 101-629, Sec. 14(a), added subsec. (m).


                    Effective Date of 1997 Amendment

    Amendment by sections 201(a), 203, 216(a)(1), and 410(a) of Pub. L. 
105-115 effective 90 days after Nov. 21, 1997, except as otherwise 
provided, see section 501 of Pub. L. 105-115, set out as a note under 
section 321 of this title.


                    Effective Date of 1990 Amendment

    Section 14(b) of Pub. L. 101-629 provided that: ``Subsection (m) of 
section 520 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 
360j(m)], as added by the amendment made by subsection (a), shall take 
effect on the effective date of the regulations issued by the Secretary 
under paragraph (6) of such subsection.''


                Report on Humanitarian Device Exemptions

    Section 14(c) of Pub. L. 101-629 directed Secretary of Health and 
Human Services, within 4 years after issuance of regulations under 21 
U.S.C. 360j(m)(6), to report to Congress on types of devices exempted, 
an evaluation of effects of such section, and a recommendation on 
extension of the section.


         References in Other Laws to GS-16, 17, or 18 Pay Rates

    References in laws to the rates of pay for GS-16, 17, or 18, or to 
maximum rates of pay under the General Schedule, to be considered 
references to rates payable under specified sections of Title 5, 
Government Organization and Employees, see section 529 [title I, 
Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note under section 5376 
of Title 5.

                  Section Referred to in Other Sections

    This section is referred to in sections 331, 333, 351, 352, 353, 
360c, 360d, 360e, 360g, 360i, 360bbb, 374, 381, 382, 383, 1604 of this 
title.
