
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: 21USC360d]

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


(a) Reasonable assurance of safe and effective performance; periodic 
        evaluation

    (1) The special controls required by section 360c(a)(1)(B) of this 
title shall include performance standards for a class II device if the 
Secretary determines that a performance standard is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. A 
class III device may also be considered a class II device for purposes 
of establishing a standard for the device under subsection (b) of this 
section if the device has been reclassified as a class II device under a 
regulation under section 360c(e) of this title but such regulation 
provides that the reclassification is not to take effect until the 
effective date of such a standard for the device.
    (2) A performance standard established under subsection (b) of this 
section for a device--
        (A) shall include provisions to provide reasonable assurance of 
    its safe and effective performance;
        (B) shall, where necessary to provide reasonable assurance of 
    its safe and effective performance, include--
            (i) provisions respecting the construction, components, 
        ingredients, and properties of the device and its compatibility 
        with power systems and connections to such systems,
            (ii) provisions for the testing (on a sample basis or, if 
        necessary, on an individual basis) of the device or, if it is 
        determined that no other more practicable means are available to 
        the Secretary to assure the conformity of the device to the 
        standard, provisions for the testing (on a sample basis or, if 
        necessary, on an individual basis) by the Secretary or by 
        another person at the direction of the Secretary,
            (iii) provisions for the measurement of the performance 
        characteristics of the device,
            (iv) provisions requiring that the results of each or of 
        certain of the tests of the device required to be made under 
        clause (ii) show that the device is in conformity with the 
        portions of the standard for which the test or tests were 
        required, and
            (v) a provision requiring that the sale and distribution of 
        the device be restricted but only to the extent that the sale 
        and distribution of a device may be restricted under a 
        regulation under section 360j(e) of this title; and

        (C) shall, where appropriate, require the use and prescribe the 
    form and content of labeling for the proper installation, 
    maintenance, operation, and use of the device.

    (3) The Secretary shall provide for periodic evaluation of 
performance standards established under subsection (b) of this section 
to determine if such standards should be changed to reflect new medical, 
scientific, or other technological data.
    (4) In carrying out his duties under this subsection and subsection 
(b) of this section, the Secretary shall, to the maximum extent 
practicable--
        (A) use personnel, facilities, and other technical support 
    available in other Federal agencies,
        (B) consult with other Federal agencies concerned with standard-
    setting and other nationally or internationally recognized standard-
    setting entities, and
        (C) invite appropriate participation, through joint or other 
    conferences, workshops, or other means, by informed persons 
    representative of scientific, professional, industry, or consumer 
    organizations who in his judgment can make a significant 
    contribution.

(b) Establishment of a standard

    (1)(A) The Secretary shall publish in the Federal Register a notice 
of proposed rulemaking for the establishment, amendment, or revocation 
of any performance standard for a device.
    (B) A notice of proposed rulemaking for the establishment or 
amendment of a performance standard for a device shall--
        (i) set forth a finding with supporting justification that the 
    performance standard is appropriate and necessary to provide 
    reasonable assurance of the safety and effectiveness of the device,
        (ii) set forth proposed findings with respect to the risk of 
    illness or injury that the performance standard is intended to 
    reduce or eliminate,
        (iii) invite interested persons to submit to the Secretary, 
    within 30 days of the publication of the notice, requests for 
    changes in the classification of the device pursuant to section 
    360c(e) of this title based on new information relevant to the 
    classification, and
        (iv) invite interested persons to submit an existing performance 
    standard for the device, including a draft or proposed performance 
    standard, for consideration by the Secretary.

    (C) A notice of proposed rulemaking for the revocation of a 
performance standard shall set forth a finding with supporting 
justification that the performance standard is no longer necessary to 
provide reasonable assurance of the safety and effectiveness of a 
device.
    (D) The Secretary shall provide for a comment period of not less 
than 60 days.
    (2) If, after publication of a notice in accordance with paragraph 
(1), the Secretary receives a request for a change in the classification 
of the device, the Secretary shall, within 60 days of the publication of 
the notice, after consultation with the appropriate panel under section 
360c of this title, either deny the request or give notice of an intent 
to initiate such change under section 360c(e) of this title.
    (3)(A) After the expiration of the period for comment on a notice of 
proposed rulemaking published under paragraph (1) respecting a 
performance standard and after consideration of such comments and any 
report from an advisory committee under paragraph (5), the Secretary 
shall (i) promulgate a regulation establishing a performance standard 
and publish in the Federal Register findings on the matters referred to 
in paragraph (1), or (ii) publish a notice terminating the proceeding 
for the development of the standard together with the reasons for such 
termination. If a notice of termination is published, the Secretary 
shall (unless such notice is issued because the device is a banned 
device under section 360f of this title) initiate a proceeding under 
section 360c(e) of this title to reclassify the device subject to the 
proceeding terminated by such notice.
    (B) A regulation establishing a performance standard shall set forth 
the date or dates upon which the standard shall take effect, but no such 
regulation may take effect before one year after the date of its 
publication unless (i) the Secretary determines that an earlier 
effective date is necessary for the protection of the public health and 
safety, or (ii) such standard has been established for a device which, 
effective upon the effective date of the standard, has been reclassified 
from class III to class II. Such date or dates shall be established so 
as to minimize, consistent with the public health and safety, economic 
loss to, and disruption or dislocation of, domestic and international 
trade.
    (4)(A) The Secretary, upon his own initiative or upon petition of an 
interested person may by regulation, promulgated in accordance with the 
requirements of paragraphs (1), (2), and (3)(B) of this subsection, 
amend or revoke a performance standard.
    (B) The Secretary may declare a proposed amendment of a performance 
standard to be effective on and after its publication in the Federal 
Register and until the effective date of any final action taken on such 
amendment if he determines that making it so effective is in the public 
interest. A proposed amendment of a performance standard made so 
effective under the preceding sentence may not prohibit, during the 
period in which it is so effective, the introduction or delivery for 
introduction into interstate commerce of a device which conforms to such 
standard without the change or changes provided by such proposed 
amendment.
    (5)(A) The Secretary--
        (i) may on his own initiative refer a proposed regulation for 
    the establishment, amendment, or revocation of a performance 
    standard, or
        (ii) shall, upon the request of an interested person which 
    demonstrates good cause for referral and which is made before the 
    expiration of the period for submission of comments on such proposed 
    regulation refer such proposed regulation,

to an advisory committee of experts, established pursuant to 
subparagraph (B), for a report and recommendation with respect to any 
matter involved in the proposed regulation which requires the exercise 
of scientific judgment. If a proposed regulation is referred under this 
subparagraph to an advisory committee, the Secretary shall provide the 
advisory committee with the data and information on which such proposed 
regulation is based. The advisory committee shall, within sixty days of 
the referral of a proposed regulation and after independent study of the 
data and information furnished to it by the Secretary and other data and 
information before it, submit to the Secretary a report and 
recommendation respecting such regulation, together with all underlying 
data and information and a statement of the reason or basis for the 
recommendation. A copy of such report and recommendation shall be made 
public by the Secretary.
    (B) The Secretary shall establish advisory committees (which may not 
be panels under section 360c of this title) to receive referrals under 
subparagraph (A). The Secretary shall appoint as members of any such 
advisory committee persons qualified in the subject matter to be 
referred to the committee and of appropriately diversified professional 
background, except that the Secretary may not appoint to such a 
committee any individual who is in the regular full-time employ of the 
United States and engaged in the administration of this chapter. Each 
such committee shall include as nonvoting members a representative of 
consumer interests and a representative of interests of the device 
manufacturing industry. Members of an advisory committee who are not 
officers or employees of the United States, while attending conferences 
or meetings of their committee or otherwise serving at the request of 
the Secretary, shall be entitled to receive compensation at rates to be 
fixed by the Secretary, which rates may not exceed the daily equivalent 
of the rate in effect for grade GS-18 of the General Schedule, for each 
day (including traveltime) they are so engaged; and while so serving 
away from their homes or regular places of business each member may be 
allowed travel expenses, including per diem in lieu of subsistence, as 
authorized by section 5703 of title 5 for persons in the Government 
service employed intermittently. The Secretary shall designate one of 
the members of each advisory committee to serve as chairman thereof. The 
Secretary shall furnish each advisory committee with clerical and other 
assistance, and shall by regulation prescribe the procedures to be 
followed by each such committee in acting on referrals made under 
subparagraph (A).

(c) Recognition of standard

    (1)(A) In addition to establishing a performance standard under this 
section, the Secretary shall, by publication in the Federal Register, 
recognize all or part of an appropriate standard established by a 
nationally or internationally recognized standard development 
organization for which a person may submit a declaration of conformity 
in order to meet a premarket submission requirement or other requirement 
under this chapter to which such standard is applicable.
    (B) If a person elects to use a standard recognized by the Secretary 
under subparagraph (A) to meet the requirements described in such 
subparagraph, the person shall provide a declaration of conformity to 
the Secretary that certifies that the device is in conformity with such 
standard. A person may elect to use data, or information, other than 
data required by a standard recognized under subparagraph (A) to meet 
any requirement regarding devices under this chapter.
    (2) The Secretary may withdraw such recognition of a standard 
through publication of a notice in the Federal Register if the Secretary 
determines that the standard is no longer appropriate for meeting a 
requirement regarding devices under this chapter.
    (3)(A) Subject to subparagraph (B), the Secretary shall accept a 
declaration of conformity that a device is in conformity with a standard 
recognized under paragraph (1) unless the Secretary finds--
        (i) that the data or information submitted to support such 
    declaration does not demonstrate that the device is in conformity 
    with the standard identified in the declaration of conformity; or
        (ii) that the standard identified in the declaration of 
    conformity is not applicable to the particular device under review.

    (B) The Secretary may request, at any time, the data or information 
relied on by the person to make a declaration of conformity with respect 
to a standard recognized under paragraph (1).
    (C) A person making a declaration of conformity with respect to a 
standard recognized under paragraph (1) shall maintain the data and 
information demonstrating conformity of the device to the standard for a 
period of two years after the date of the classification or approval of 
the device by the Secretary or a period equal to the expected design 
life of the device, whichever is longer.

(June 25, 1938, ch. 675, Sec. 514, as added Pub. L. 94-295, Sec. 2, May 
28, 1976, 90 Stat. 546; amended Pub. L. 94-460, title III, Sec. 304, 
Oct. 8, 1976, 90 Stat. 1960; Pub. L. 101-629, Secs. 6(a), (b)(1), 18(b), 
Nov. 28, 1990, 104 Stat. 4519, 4528; Pub. L. 102-300, Sec. 6(g), June 
16, 1992, 106 Stat. 241; Pub. L. 103-80, Sec. 4(a)(1), Aug. 13, 1993, 
107 Stat. 779; Pub. L. 105-115, title II, Sec. 204(a), (d), Nov. 21, 
1997, 111 Stat. 2335, 2336.)


                               Amendments

    1997--Subsec. (a)(1). Pub. L. 105-115, Sec. 204(d)(1), substituted 
``under subsection (b) of this section'' for ``under this section''.
    Subsec. (a)(2). Pub. L. 105-115, Sec. 204(d)(2), substituted ``under 
subsection (b) of this section'' for ``under this section'' in 
introductory provisions.
    Subsec. (a)(3). Pub. L. 105-115, Sec. 204(d)(3), substituted ``under 
subsection (b) of this section'' for ``under this section''.
    Subsec. (a)(4). Pub. L. 105-115, Sec. 204(d)(4), substituted ``this 
subsection and subsection (b) of this section'' for ``this section'' in 
introductory provisions.
    Subsec. (c). Pub. L. 105-115, Sec. 204(a), added subsec. (c).
    1993--Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 103-80 amended 
directory language of Pub. L. 101-619, Sec. 18(b), identical to 
amendment by Pub. L. 102-300, Sec. 6(g)(1). See 1992 and 1990 Amendment 
notes below.
    1992--Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 102-300 made technical 
corrections to directory language of Pub. L. 101-629, Sec. 18(b)(1), 
(2). See 1990 Amendment note below.
    1990--Subsec. (a)(1). Pub. L. 101-629, Sec. 6(a)(1), substituted 
``The special controls required by section 360c(a)(1)(B) of this title 
shall include performance standards for a class II device if the 
Secretary determines that a performance standard is necessary to provide 
reasonable assurance of the safety and effectiveness of the device.'' 
for ``The Secretary may by regulation, promulgated in accordance with 
this section, establish a performance standard for a class II device.''
    Subsec. (b). Pub. L. 101-629, Sec. 6(a)(2), (3), redesignated 
subsec. (g) as (b) and struck out former subsec. (b) which read as 
follows:
    ``(1) A proceeding for the development of a performance standard for 
a device shall be initiated by the Secretary by the publication in the 
Federal Register of notice of the opportunity to submit to the Secretary 
a request (within fifteen days of the date of the publication of the 
notice) for a change in the classification of the device based on new 
information relevant to its classification.
    ``(2) If, after publication of a notice pursuant to paragraph (1) 
the Secretary receives a request for a change in the device's 
classification, 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.''
    Subsec. (b)(1), (2). Pub. L. 101-629, Sec. 6(a)(4), amended pars. 
(1) and (2) generally. Prior to amendment, pars. (1) and (2) read as 
follows:
    ``(1)(A) After publication pursuant to subsection (c) of this 
section of a notice respecting a performance standard for a device, the 
Secretary shall either--
        ``(i) publish, in the Federal Register in a notice of proposed 
    rulemaking, a proposed performance standard for the device (I) 
    developed by an offeror under such notice and accepted by the 
    Secretary, (II) developed under subsection (c)(4) of this section, 
    (III) accepted by the Secretary under subsection (d) of this 
    section, or (IV) developed by him under subsection (f) of this 
    section, or
        ``(ii) issue a notice in the Federal Register that the 
    proceeding is terminated together with the reasons for such 
    termination.
    ``(B) If the Secretary issues under subparagraph (A)(ii) a notice of 
termination of a proceeding to establish a performance standard for a 
device, he 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.
    ``(2) A notice of proposed rulemaking for the establishment of a 
performance standard for a device published under paragraph (1)(A)(i) 
shall set forth proposed findings with respect to the degree of the risk 
of illness or injury designed to be eliminated or reduced by the 
proposed standard and the benefit to the public from the device.''
    Subsec. (b)(3)(A)(i). Pub. L. 101-629, Sec. 6(b)(1)(A), substituted 
``paragraph (1)'' for ``paragraph (2)''.
    Subsec. (b)(4)(A). Pub. L. 101-629, Sec. 6(b)(1)(B), substituted 
``paragraphs (1), (2), and (3)(B)'' for ``paragraphs (2) and (3)(B)''.
    Subsec. (b)(4)(B). Pub. L. 101-629, Sec. 18(b)(1), as amended by 
Pub. L. 102-300, Sec. 6(g)(1), (2), and Pub. L. 103-80, Sec. 4(a)(1), 
struck out ``, after affording all interested persons an opportunity for 
an informal hearing,'' after ``if he determines''.
    Subsec. (b)(5)(A)(ii). Pub. L. 101-629, Sec. 18(b)(2), as amended by 
Pub. L. 102-300, Sec. 6(g)(1), (3), and Pub. L. 103-80, Sec. 4(a)(1), 
substituted ``which demonstrates good cause for referral and which is 
made before the expiration of the period for submission of comments on 
such proposed regulation refer such proposed regulation,'' for ``unless 
the Secretary finds the request to be without good cause or the request 
is made after the expiration of the period for submission of comments on 
such proposed regulation refer such proposed regulation,''.
    Subsecs. (c) to (f). Pub. L. 101-629, Sec. 6(a)(2), struck out 
subsec. (c) relating to invitations for standards, subsec. (d) relating 
to acceptance of certain existing standards, subsec. (e) relating to 
acceptance of offers to develop standards, and subsec. (f) relating to 
development of standards by the Secretary after publication of notice 
inviting submissions or offers of standards.
    Subsec. (g). Pub. L. 101-629, Sec. 6(a)(3), redesignated subsec. (g) 
as (b).
    1976--Subsec. (a). Pub. L. 94-460 redesignated pars. (4) and (5) as 
(3) and (4), respectively. Section as originally enacted contained no 
par. (3).


                    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.


         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.


                   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.

                  Section Referred to in Other Sections

    This section is referred to in sections 331, 351, 352, 360, 360c, 
360e, 360g, 360j, 381, 382 of this title.
