
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: 21USC360c]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 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 1 or more 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.
    (C) In making a determination of a reasonable assurance of the 
effectiveness of a device for which an application under section 360e of 
this title has been submitted, the Secretary shall consider whether the 
extent of data that otherwise would be required for approval of the 
application with respect to effectiveness can be reduced through 
reliance on postmarket controls.
    (D)(i) The Secretary, upon the written request of any person 
intending to submit an application under section 360e of this title, 
shall meet with such person to determine the type of valid scientific 
evidence (within the meaning of subparagraphs (A) and (B)) that will be 
necessary to demonstrate for purposes of approval of an application the 
effectiveness of a device for the conditions of use proposed by such 
person. 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 for determining whether there is a reasonable 
assurance of effectiveness, and, if available, information regarding the 
expected performance from the device. Within 30 days after such meeting, 
the Secretary shall specify in writing the type of valid scientific 
evidence that will provide a reasonable assurance that a device is 
effective under the conditions of use proposed by such person.
    (ii) Any clinical data, including one or more well-controlled 
investigations, specified in writing by the Secretary for demonstrating 
a reasonable assurance of device effectiveness shall be specified as 
result of a determination by the Secretary that such data are necessary 
to establish device effectiveness. The Secretary shall consider, in 
consultation with the applicant, the least burdensome appropriate means 
of evaluating device effectiveness that would have a reasonable 
likelihood of resulting in approval.
    (iii) The determination of the Secretary with respect to the 
specification of valid scientific evidence under clauses (i) and (ii) 
shall be binding upon the Secretary, unless such determination by the 
Secretary could be contrary to the public health.

(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.
    (5) Classification panels covering each type of device shall be 
scheduled to meet at such times as may be appropriate for the Secretary 
to meet applicable statutory deadlines.
    (6)(A) Any person whose device is specifically the subject of review 
by a classification panel shall have--
        (i) the same access to data and information submitted to a 
    classification panel (except for data and information that are not 
    available for public disclosure under section 552 of title 5) as the 
    Secretary;
        (ii) the opportunity to submit, for review by a classification 
    panel, information that is based on the data or information provided 
    in the application submitted under section 360e of this title by the 
    person, which information shall be submitted to the Secretary for 
    prompt transmittal to the classification panel; and
        (iii) the same opportunity as the Secretary to participate in 
    meetings of the panel.

    (B) Any meetings of a classification panel shall provide adequate 
time for initial presentations and for response to any differing views 
by persons whose devices are specifically the subject of a 
classification panel review, and shall encourage free and open 
participation by all interested persons.
    (7) After receiving from a classification panel the conclusions and 
recommendations of the panel on a matter that the panel has reviewed, 
the Secretary shall review the conclusions and recommendations, shall 
make a final decision on the matter in accordance with section 
360e(d)(2) of this title, and shall notify the affected persons of the 
decision in writing and, if the decision differs from the conclusions 
and recommendations of the panel, shall include the reasons for the 
difference.
    (8) A classification panel under this subsection shall not be 
subject to the annual chartering and annual report requirements of the 
Federal Advisory Committee Act.

(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

    (1) Any device intended for human use which was not introduced or 
delivered for introduction into interstate commerce for commercial 
distribution before May 28, 1976, is classified in class III unless--
        (A) the device--
            (i) is within a type of device (I) which was introduced or 
        delivered for introduction into interstate commerce for 
        commercial distribution before such date and which is to be 
        classified pursuant to subsection (b) of this section, or (II) 
        which was not so introduced or delivered before such date and 
        has been classified in class I or II, and
            (ii) is substantially equivalent to another device within 
        such type, or

        (B) the Secretary in response to a petition submitted under 
    paragraph (3) has classified such device in class I or II.

A device classified in class III under this paragraph shall be 
classified in that class until the effective date of an order of the 
Secretary under paragraph (2) or (3) classifying the device in class I 
or II.
    (2)(A) Any person who submits a report under section 360(k) of this 
title for a type of device that has not been previously classified under 
this chapter, and that is classified into class III under paragraph (1), 
may request, within 30 days after receiving written notice of such a 
classification, the Secretary to classify the device under the criteria 
set forth in subparagraphs (A) through (C) of subsection (a)(1) of this 
section. The person may, in the request, recommend to the Secretary a 
classification for the device. Any such request shall describe the 
device and provide detailed information and reasons for the recommended 
classification.
    (B)(i) Not later than 60 days after the date of the submission of 
the request under subparagraph (A), the Secretary shall by written order 
classify the device involved. Such classification shall be the initial 
classification of the device for purposes of paragraph (1) and any 
device classified under this paragraph shall be a predicate device for 
determining substantial equivalence under paragraph (1).
    (ii) A device that remains in class III under this subparagraph 
shall be deemed to be adulterated within the meaning of section 
351(f)(1)(B) of this title until approved under section 360e of this 
title or exempted from such approval under section 360j(g) of this 
title.
    (C) Within 30 days after the issuance of an order classifying a 
device under this paragraph, the Secretary shall publish a notice in the 
Federal Register announcing such classification.
    (3)(A) 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.
    (B)(i) Upon determining that a petition does not contain any 
deficiency which prevents the Secretary from making a decision on the 
petition, the Secretary may for good cause shown refer the petition to 
an appropriate panel established or authorized to be used under 
subsection (b) of this section. A panel to which such a petition has 
been referred shall not later than ninety days after the referral of the 
petition make a recommendation to the Secretary respecting approval or 
denial of the petition. Any such recommendation shall 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 petition was filed. In the case of a petition for a device 
which is intended to be implanted in the human body or which is 
purported or represented to be for a use in supporting or sustaining 
human life, the panel shall recommend that the petition be denied unless 
the panel determines that the classification in class III of the device 
is not necessary to provide reasonable assurance of its safety and 
effectiveness. If the panel recommends that such petition be approved, 
it shall in its recommendation to the Secretary set forth its reasons 
for such recommendation.
    (ii) The requirements of paragraphs (1) and (2) of subsection (c) of 
this section (relating to opportunities for submission of data and views 
and recommendations respecting priorities and exemptions from sections 
360, 360i, and 360j(f) of this title) shall apply with respect to 
consideration by panels of petitions submitted under subparagraph (A).
    (C)(i) Within ninety days from the date the Secretary receives the 
recommendation of a panel respecting a petition (but not later than 210 
days after the filing of such petition) the Secretary shall by order 
deny or approve the petition. If the Secretary approves the petition, 
the Secretary shall order the classification of the device into class I 
or class II in accordance with the criteria prescribed by subsection 
(a)(1)(A) or (a)(1)(B) of this section. In the case of a petition for a 
device which is intended to be implanted in the human body or which is 
purported or represented to be for a use in supporting or sustaining 
human life, the Secretary shall deny the petition unless the Secretary 
determines that the classification in class III of the device is not 
necessary to provide reasonable assurance of its safety and 
effectiveness. An order approving such petition shall be accompanied by 
a full statement of the reasons of the Secretary (and supporting 
documentation and data) for approving the petition and an identification 
of the risks to health (if any) presented by the device to which such 
order applies.
    (ii) The requirements of paragraphs (1) and (2)(A) of subsection (d) 
of this section (relating to publication of recommendations, opportunity 
for submission of comments, and exemption from sections 360, 360i, and 
360j(f) of this title) shall apply with respect to action by the 
Secretary on petitions submitted under subparagraph (A).
    (4) If a manufacturer reports to the Secretary under section 360(k) 
of this title that a device is substantially equivalent to another 
device--
        (A) which the Secretary has classified as a class III device 
    under subsection (b) of this section,
        (B) which was introduced or delivered for introduction into 
    interstate commerce for commercial distribution before December 1, 
    1990, and
        (C) for which no final regulation requiring premarket approval 
    has been promulgated under section 360e(b) of this title,

the manufacturer shall certify to the Secretary that the manufacturer 
has conducted a reasonable search of all information known or otherwise 
available to the manufacturer respecting such other device and has 
included in the report under section 360(k) of this title a summary of 
and a citation to all adverse safety and effectiveness data respecting 
such other device and respecting the device for which the section 360(k) 
report is being made and which has not been submitted to the Secretary 
under section 360i of this title. The Secretary may require the 
manufacturer to submit the adverse safety and effectiveness data 
described in the report.
    (5) The Secretary may not withhold a determination of the initial 
classification of a device under paragraph (1) because of a failure to 
comply with any provision of this chapter unrelated to a substantial 
equivalence decision, including a finding that the facility in which the 
device is manufactured is not in compliance with good manufacturing 
requirements as set forth in regulations of the Secretary under section 
360j(f) of this title (other than a finding that there is a substantial 
likelihood that the failure to comply with such regulations will 
potentially present a serious risk to human health).

(g) Information

    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.

(h) Definitions

    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 appropriate 
    clinical or scientific data if deemed necessary by the Secretary or 
    a person accredited under section 360m of this title, 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 effectiveness 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.
    (C) To facilitate reviews of reports submitted to the Secretary 
under section 360(k) of this title, the Secretary shall consider the 
extent to which reliance on postmarket controls may expedite the 
classification of devices under subsection (f)(1) of this section.
    (D) Whenever the Secretary requests information to demonstrate that 
devices with differing technological characteristics are substantially 
equivalent, the Secretary shall only request information that is 
necessary to making substantial equivalence determinations. In making 
such request, the Secretary shall consider the least burdensome means of 
demonstrating substantial equivalence and request information 
accordingly.
    (E)(i) Any determination by the Secretary of the intended use of a 
device shall be based upon the proposed labeling submitted in a report 
for the device under section 360(k) of this title. However, when 
determining that a device can be found substantially equivalent to a 
legally marketed device, the director of the organizational unit 
responsible for regulating devices (in this subparagraph referred to as 
the ``Director'') may require a statement in labeling that provides 
appropriate information regarding a use of the device not identified in 
the proposed labeling if, after providing an opportunity for 
consultation with the person who submitted such report, the Director 
determines and states in writing--
        (I) that there is a reasonable likelihood that the device will 
    be used for an intended use not identified in the proposed labeling 
    for the device; and
        (II) that such use could cause harm.

    (ii) Such determination shall--
        (I) be provided to the person who submitted the report within 10 
    days from the date of the notification of the Director's concerns 
    regarding the proposed labeling;
        (II) specify the limitations on the use of the device not 
    included in the proposed labeling; and
        (III) find the device substantially equivalent if the 
    requirements of subparagraph (A) are met and if the labeling for 
    such device conforms to the limitations specified in subclause (II).

    (iii) The responsibilities of the Director under this subparagraph 
may not be delegated.
    (iv) This subparagraph has no legal effect after the expiration of 
the five-year period beginning on November 21, 1997.
    (F) Not later than 270 days after November 21, 1997, the Secretary 
shall issue guidance specifying the general principles that the 
Secretary will consider in determining when a specific intended use of a 
device is not reasonably included within a general use of such device 
for purposes of a determination of substantial equivalence under 
subsection (f) of this section or section 360j(l) of this title.
    (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.

(June 25, 1938, ch. 675, Sec. 513, as added Pub. L. 94-295, Sec. 2, May 
28, 1976, 90 Stat. 540; amended Pub. L. 101-629, Secs. 4(a), 5(a)-
(c)(1), (3), 12(a), 18(a), Nov. 28, 1990, 104 Stat. 4515, 4517, 4518, 
4523, 4528; Pub. L. 102-300, Sec. 6(e), June 16, 1992, 106 Stat. 240; 
Pub. L. 103-80, Sec. 3(s), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-
115, title II, Secs. 205(a), (b), 206(b), (c), 207, 208, 217, Nov. 21, 
1997, 111 Stat. 2336, 2337, 2339, 2340, 2350.)

                       References in Text

    The Federal Advisory Committee Act, referred to in subsec. (b)(1), 
(8), is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is 
set out in the Appendix to Title 5, Government Organization and 
Employees.


                               Amendments

    1997--Subsec. (a)(3)(A). Pub. L. 105-115, Sec. 217, substituted ``1 
or more clinical investigations'' for ``clinical investigations''.
    Subsec. (a)(3)(C), (D). Pub. L. 105-115, Sec. 205(a), added subpars. 
(C) and (D).
    Subsec. (b)(5) to (8). Pub. L. 105-115, Sec. 208, added pars. (5) to 
(8).
    Subsec. (f)(1). Pub. L. 105-115, Sec. 207(1)(B), substituted 
``paragraph (2) or (3)'' for ``paragraph (2)'' in closing provisions.
    Subsec. (f)(1)(B). Pub. L. 105-115, Sec. 207(1)(A), substituted 
``paragraph (3)'' for ``paragraph (2)''.
    Subsec. (f)(2) to (4). Pub. L. 105-115, Sec. 207(2), (3), added par. 
(2) and redesignated former pars. (2) and (3) as (3) and (4), 
respectively.
    Subsec. (f)(5). Pub. L. 105-115, Sec. 206(b), added par. (5).
    Subsec. (i)(1)(A)(ii). Pub. L. 105-115, Sec. 206(c)(1), substituted 
``appropriate clinical or scientific data'' for ``clinical data'', 
inserted ``or a person accredited under section 360m of this title'' 
after ``Secretary'', and substituted ``effectiveness'' for ``efficacy''.
    Subsec. (i)(1)(C) to (E). Pub. L. 105-115, Sec. 205(b), added 
subpars. (C) to (E).
    Subsec. (i)(1)(F). Pub. L. 105-115, Sec. 206(c)(2), added subpar. 
(F).
    1993--Subsec. (b)(3). Pub. L. 103-80 substituted ``5703'' for 
``5703(b)''.
    1992--Subsec. (f)(3). Pub. L. 102-300 redesignated clauses (i) to 
(iii) as subpars. (A) to (C), respectively, and substituted ``the 
section 360(k) report'' for ``the 360(k) report'' in closing provisions.
    1990--Subsec. (a)(1)(A)(ii). Pub. L. 101-629, Sec. 5(a)(1), 
substituted ``or to establish special controls'' for ``or to establish a 
performance standard''.
    Subsec. (a)(1)(B). Pub. L. 101-629, Sec. 5(a)(2), amended subpar. 
(B) generally. Prior to amendment, subpar. (B) read as follows: ``Class 
II, Performance Standards.--A device which cannot be classified as a 
class I device because the controls authorized by or under sections 351, 
352, 360, 360f, 360h, 360i, and 360j of this title by themselves are 
insufficient to provide reasonable assurance of the safety and 
effectiveness of the device, for which there is sufficient information 
to establish a performance standard to provide such assurance, and for 
which it is therefore necessary to establish for the device a 
performance standard under section 360d of this title to provide 
reasonable assurance of its safety and effectiveness.''
    Subsec. (a)(1)(C)(i). Pub. L. 101-629, Sec. 5(a)(3), amended cl. (i) 
generally. Prior to amendment, cl. (i) read as follows: ``it (I) cannot 
be classified as a class I device because insufficient information 
exists to determine that the controls authorized by or under sections 
351, 352, 360, 360f, 360h, 360i, and 360j of this title 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 for the establishment of a performance 
standard to provide reasonable assurance of its safety and 
effectiveness, and''.
    Subsec. (e). Pub. L. 101-629, Sec. 5(b), designated existing 
provisions as par. (1), redesignated cls. (1) and (2) as (A) and (B), 
respectively, and added par. (2).
    Subsec. (f). Pub. L. 101-629, Sec. 5(c)(3), inserted ``and 
reclassification'' before ``of'' in heading.
    Subsec. (f)(2)(A). Pub. L. 101-629, Sec. 5(c)(1), 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. (f)(2)(B)(i). Pub. L. 101-629, Sec. 18(a), substituted ``the 
Secretary may for good cause shown'' for ``the Secretary shall''.
    Subsec. (f)(3). Pub. L. 101-629, Sec. 4(a), added par. (3).
    Subsec. (i). Pub. L. 101-629, Sec. 12(a), 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.


                      Short Title of 1976 Amendment

    Pub. L. 94-295, Sec. 1(a), May 28, 1976, 90 Stat. 539, provided 
that: ``This Act [enacting sections 360c to 360k, 379, and 379a of this 
title and section 3512 of Title 42, The Public Health and Welfare, and 
amending sections 321, 331, 334, 351, 352, 358, 360, 374, 379e, and 381 
of this title and section 55 of Title 15, Commerce and Trade] may be 
cited as the `Medical Device Amendments of 1976'.''


                               Regulations

    Section 12(b) of Pub. L. 101-629 provided that: ``Within 12 months 
of the date of the enactment of this Act [Nov. 28, 1990], the Secretary 
of Health and Human Services shall issue regulations establishing the 
requirements of the summaries under section 513(i)(3) of the Federal 
Food, Drug, and Cosmetic Act [21 U.S.C. 360c(i)(3)], as added by the 
amendment made by subsection (a).''


   Daily Wear Soft or Daily Wear Nonhydrophilic Plastic Contact Lenses

    Section 4(b)(3) of Pub. L. 101-629 provided that:
    ``(A) Notwithstanding section 520(l)(5) of the Federal Food, Drug, 
and Cosmetic Act [21 U.S.C. 360j(l)(5)], the Secretary of Health and 
Human Services shall not retain any daily wear soft or daily wear 
nonhydrophilic plastic contact lens in class III under such Act [this 
chapter] unless the Secretary finds that it meets the criteria set forth 
in section 513(a)(1)(C) of such Act [21 U.S.C. 360c(a)(1)(C)]. The 
finding and the grounds for the finding shall be published in the 
Federal Register. For any such lens, the Secretary shall make the 
determination respecting reclassification required in section 
520(l)(5)(B) of such Act within 24 months of the date of the enactment 
of this paragraph [Nov. 28, 1990].
    ``(B) The Secretary of Health and Human Services may by notice 
published in the Federal Register extend the two-year period prescribed 
by subparagraph (A) for a lens for an additional period not to exceed 
one year.
    ``(C)(i) Before classifying a lens in class II pursuant to 
subparagraph (A), the Secretary of Health and Human Services shall 
pursuant to section 513(a)(1)(B) of such Act assure that appropriate 
regulatory safeguards are in effect which provide reasonable assurance 
of the safety and effectiveness of such lens, including clinical and 
preclinical data if deemed necessary by the Secretary.
    ``(ii) Prior to classifying a lens in class I pursuant to 
subparagraph (A), the Secretary shall assure that appropriate regulatory 
safeguards are in effect which provide reasonable assurance of the 
safety and effectiveness of such lens, including clinical and 
preclinical data if deemed necessary by the Secretary.
    ``(D) Notwithstanding section 520(l)(5) of such Act, if the 
Secretary of Health and Human Services has not made the finding and 
published the finding required by subparagraph (A) within 36 months of 
the date of the enactment of this subparagraph [Nov. 28, 1990], the 
Secretary shall issue an order placing the lens in class II.
    ``(E) Any person adversely affected by a final regulation under this 
paragraph revising the classification of a lens may challenge the 
revision of the classification of such lens only by filing a petition 
under section 513(e) for a classification change.''


         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, 360, 360d, 360e, 
360g, 360j, 360m, 360aaa, 1604 of this title.
