
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360e]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 360e. Premarket approval


(a) General requirement

    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.

In making the determination whether to approve or deny the application, 
the Secretary shall rely on the conditions of use included in the 
proposed labeling as the basis for determining whether or not there is a 
reasonable assurance of safety and effectiveness, if the proposed 
labeling is neither false nor misleading. In determining whether or not 
such labeling is false or misleading, the Secretary shall fairly 
evaluate all material facts pertinent to the proposed labeling.
    (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.
    (iii) The Secretary shall accept and review statistically valid and 
reliable data and any other information from investigations conducted 
under the authority of regulations required by section 360j(g) of this 
title to make a determination of whether there is a reasonable assurance 
of safety and effectiveness of a device subject to a pending application 
under this section if--
        (I) the data or information is derived from investigations of an 
    earlier version of the device, the device has been modified during 
    or after the investigations (but prior to submission of an 
    application under subsection (c) of this section) and such a 
    modification of the device does not constitute a significant change 
    in the design or in the basic principles of operation of the device 
    that would invalidate the data or information; or
        (II) the data or information relates to a device approved under 
    this section, is available for use under this chapter, and is 
    relevant to the design and intended use of the device for which the 
    application is pending.

    (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)(A)(i) The Secretary shall, upon the written request of an 
applicant, meet with the applicant, not later than 100 days after the 
receipt of an application that has been filed as complete under 
subsection (c) of this section, to discuss the review status of the 
application.
    (ii) The Secretary shall, in writing and prior to the meeting, 
provide to the applicant a description of any deficiencies in the 
application that, at that point, have been identified by the Secretary 
based on an interim review of the entire application and identify the 
information that is required to correct those deficiencies.
    (iii) The Secretary shall notify the applicant promptly of--
        (I) any additional deficiency identified in the application, or
        (II) any additional information required to achieve completion 
    of the review and final action on the application,

that was not described as a deficiency in the written description 
provided by the Secretary under clause (ii).
    (B) The Secretary and the applicant may, by mutual consent, 
establish a different schedule for a meeting required under this 
paragraph.
    (4) 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.
    (5) In order to provide for more effective treatment or diagnosis of 
life-threatening or irreversibly debilitating human diseases or 
conditions, the Secretary shall provide review priority for devices--
        (A) representing breakthrough technologies,
        (B) for which no approved alternatives exist,
        (C) which offer significant advantages over existing approved 
    alternatives, or
        (D) the availability of which is in the best interest of the 
    patients.

    (6)(A)(i) A supplemental application shall be required for any 
change to a device subject to an approved application under this 
subsection that affects safety or effectiveness, unless such change is a 
modification in a manufacturing procedure or method of manufacturing and 
the holder of the approved application submits a written notice to the 
Secretary that describes in detail the change, summarizes the data or 
information supporting the change, and informs the Secretary that the 
change has been made under the requirements of section 360j(f) of this 
title.
    (ii) The holder of an approved application who submits a notice 
under clause (i) with respect to a manufacturing change of a device may 
distribute the device 30 days after the date on which the Secretary 
receives the notice, unless the Secretary within such 30-day period 
notifies the holder that the notice is not adequate and describes such 
further information or action that is required for acceptance of such 
change. If the Secretary notifies the holder that a supplemental 
application is required, the Secretary shall review the supplement 
within 135 days after the receipt of the supplement. The time used by 
the Secretary to review the notice of the manufacturing change shall be 
deducted from the 135-day review period if the notice meets appropriate 
content requirements for premarket approval supplements.
    (B)(i) Subject to clause (ii), in reviewing a supplement to an 
approved application, for an incremental change to the design of a 
device that affects safety or effectiveness, the Secretary shall approve 
such supplement if--
        (I) nonclinical data demonstrate that the design modification 
    creates the intended additional capacity, function, or performance 
    of the device; and
        (II) clinical data from the approved application and any 
    supplement to the approved application provide a reasonable 
    assurance of safety and effectiveness for the changed device.

    (ii) The Secretary may require, when necessary, additional clinical 
data to evaluate the design modification of the device to provide a 
reasonable assurance of safety and effectiveness.

(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, the Secretary--
        (A) may, at the initiative of the Secretary, refer the proposed 
    protocol to the appropriate panel under section 360c of this title 
    for its recommendation respecting approval of the protocol; or
        (B) shall so refer such protocol upon the request of the 
    submitter, unless the Secretary finds that the proposed protocol and 
    accompanying data which would be reviewed by such panel 
    substantially duplicate a product development protocol and 
    accompanying data which have previously been reviewed by such a 
    panel.

    (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.

(h) Service of orders

    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.

(June 25, 1938, ch. 675, Sec. 515, as added Pub. L. 94-295, Sec. 2, May 
28, 1976, 90 Stat. 552; amended Pub. L. 101-629, Secs. 4(b)(1), 9(a), 
18(c), Nov. 28, 1990, 104 Stat. 4515, 4521, 4528; Pub. L. 103-80, 
Sec. 3(t), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title II, 
Secs. 201(b), 202, 205(c), 209(b), 216(b), Nov. 21, 1997, 111 Stat. 
2334, 2338, 2341, 2349.)


                               Amendments

    1997--Subsec. (d)(1)(A). Pub. L. 105-115, Sec. 205(c)(1), inserted 
at end ``In making the determination whether to approve or deny the 
application, the Secretary shall rely on the conditions of use included 
in the proposed labeling as the basis for determining whether or not 
there is a reasonable assurance of safety and effectiveness, if the 
proposed labeling is neither false nor misleading. In determining 
whether or not such labeling is false or misleading, the Secretary shall 
fairly evaluate all material facts pertinent to the proposed labeling.''
    Subsec. (d)(1)(B)(iii). Pub. L. 105-115, Sec. 201(b), added cl. 
(iii).
    Subsec. (d)(3), (4). Pub. L. 105-115, Sec. 202(1), 209(b), added 
par. (3) and redesignated former par. (3) as (4).
    Subsec. (d)(5). Pub. L. 105-115, Sec. 202(2), added par. (5).
    Subsec. (d)(6). Pub. L. 105-115, Sec. 205(c)(2), added par. (6).
    Subsec. (f)(2). Pub. L. 105-115, Sec. 216(b), substituted ``the 
Secretary--'' and subpars. (A) and (B) for ``he shall refer the proposed 
protocol to the appropriate panel under section 360c of this title for 
its recommendation respecting approval of the protocol.''
    1993--Subsec. (c)(2)(A). Pub. L. 103-80 struck out ``refer such 
application'' after ``own initiative''.
    1990--Subsec. (c)(2). Pub. L. 101-629, Sec. 18(c), substituted ``the 
Secretary--'' for ``the Secretary shall'' and added subpars. (A) and 
(B).
    Subsec. (e). Pub. L. 101-629, Sec. 9(a)(2), inserted ``and temporary 
suspension'' after ``Withdrawal'' in heading.
    Subsec. (e)(3). Pub. L. 101-629, Sec. 9(a)(1), added par. (3).
    Subsec. (i). Pub. L. 101-629, Sec. 4(b)(1), added subsec. (i).


                    Effective Date of 1997 Amendment

    Amendment by 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.


                   Termination of Advisory Committees

    Advisory committees in existence on Jan. 5, 1973, to terminate not 
later than the expiration of the 2-year period following Jan. 5, 1973, 
and advisory committees established after Jan. 5, 1973, to terminate not 
later than the expiration of the 2-year period beginning on the date of 
their establishment, unless in the case of a committee established by 
the President or an officer of the Federal Government, such committee is 
renewed by appropriate action prior to the expiration of such 2-year 
period, or in the case of a committee established by Congress, its 
duration is otherwise provided by law. See section 14 of Pub. L. 92-463, 
Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title 5, 
Government Organization and Employees.


         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, 351, 353, 360, 360c, 
360g, 360j, 360aaa, 360bbb-1, 381, 382, 1604 of this title; title 35 
section 156.
