---
kind: "section"
citation: "21 U.S.C. § 360d"
title: "21"
title_heading: "Food and Drugs"
number: "360d"
heading: "Performance standards"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360d"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §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](/usc/21/360c.md?p=a-1-B) shall include performance standards for a class II [device](/usc/21/321.md?p=h-1) if the [Secretary](/usc/21/321.md?p=d) determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the [device](/usc/21/321.md?p=h-1). A class III [device](/usc/21/321.md?p=h-1) may also be considered a class II [device](/usc/21/321.md?p=h-1) for purposes of establishing a standard for the [device](/usc/21/321.md?p=h-1) under [subsection (b)](#b) if the [device](/usc/21/321.md?p=h-1) has been reclassified as a class II [device](/usc/21/321.md?p=h-1) under an administrative order under [section 360c(e) of this title](/usc/21/360c.md?p=e) (or a regulation promulgated under such section prior to July 9, 2012) but such order (or regulation) provides that the reclassification is not to take effect until the effective date of such a standard for the [device](/usc/21/321.md?p=h-1).
  - (2) A performance standard established under [subsection (b)](#b) for a [device](/usc/21/321.md?p=h-1)—
    - (A) shall include provisions to provide reasonable assurance of its [safe](/usc/21/321.md?p=u) and effective performance;
    - (B) shall, where necessary to provide reasonable assurance of its [safe](/usc/21/321.md?p=u) and effective performance, include—
      - (i) provisions respecting the construction, components, ingredients, and properties of the [device](/usc/21/321.md?p=h-1) 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](/usc/21/321.md?p=h-1) or, if it is determined that no other more practicable means are available to the [Secretary](/usc/21/321.md?p=d) to assure the conformity of the [device](/usc/21/321.md?p=h-1) to the standard, provisions for the testing (on a sample basis or, if necessary, on an individual basis) by the [Secretary](/usc/21/321.md?p=d) or by another [person](/usc/21/321.md?p=e) at the direction of the [Secretary](/usc/21/321.md?p=d),
      - (iii) provisions for the measurement of the performance characteristics of the [device](/usc/21/321.md?p=h-1),
      - (iv) provisions requiring that the results of each or of certain of the tests of the [device](/usc/21/321.md?p=h-1) required to be made under [clause (ii)](#a-2-B-ii) show that the [device](/usc/21/321.md?p=h-1) 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](/usc/21/360eee.md?p=5) of the [device](/usc/21/321.md?p=h-1) be restricted but only to the extent that the sale and [distribution](/usc/21/360eee.md?p=5) of a [device](/usc/21/321.md?p=h-1) may be restricted under a regulation under [section 360j(e) of this title](/usc/21/360j.md?p=e); and
    - (C) shall, where appropriate, require the use and prescribe the form and content of [labeling](/usc/21/321.md?p=m) for the proper installation, maintenance, operation, and use of the [device](/usc/21/321.md?p=h-1).
  - (3) The [Secretary](/usc/21/321.md?p=d) shall provide for periodic evaluation of performance standards established under [subsection (b)](#b) 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)](#b), the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=e) 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](/usc/21/321.md?p=d) shall publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any performance standard for a [device](/usc/21/321.md?p=h-1).
    - (B) A notice of proposed rulemaking for the establishment or amendment of a performance standard for a [device](/usc/21/321.md?p=h-1) 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](/usc/21/321.md?p=h-1),
      - (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](/usc/21/321.md?p=e) to submit to the [Secretary](/usc/21/321.md?p=d), within 30 days of the publication of the notice, requests for changes in the classification of the [device](/usc/21/321.md?p=h-1) pursuant to [section 360c(e) of this title](/usc/21/360c.md?p=e) based on new information relevant to the classification, and
      - (iv) invite interested [persons](/usc/21/321.md?p=e) to submit an existing performance standard for the [device](/usc/21/321.md?p=h-1), including a draft or proposed performance standard, for consideration by the [Secretary](/usc/21/321.md?p=d).
    - (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](/usc/21/321.md?p=h-1).
    - (D) The [Secretary](/usc/21/321.md?p=d) shall provide for a comment period of not less than 60 days.
  - (2) If, after publication of a notice in accordance with [paragraph (1)](#b-1), the [Secretary](/usc/21/321.md?p=d) receives a request for a change in the classification of the [device](/usc/21/321.md?p=h-1), the [Secretary](/usc/21/321.md?p=d) shall, within 60 days of the publication of the notice, after consultation with the appropriate panel under [section 360c of this title](/usc/21/360c.md), either deny the request or give notice of an intent to initiate such change under [section 360c(e) of this title](/usc/21/360c.md?p=e).
  - (3)
    - (A) After the expiration of the period for comment on a notice of proposed rulemaking published under [paragraph (1)](#b-1) respecting a performance standard and after consideration of such comments and any report from an [advisory committee](/usc/21/360fff.md?p=1) under [paragraph (5)](#b-5), the [Secretary](/usc/21/321.md?p=d) shall (i) promulgate a regulation establishing a performance standard and publish in the Federal Register findings on the matters referred to in paragraph [(1)](#b-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](/usc/21/321.md?p=d) shall (unless such notice is issued because the [device](/usc/21/321.md?p=h-1) is a banned [device](/usc/21/321.md?p=h-1) under [section 360f of this title](/usc/21/360f.md)) initiate a proceeding under [section 360c(e) of this title](/usc/21/360c.md?p=e) to reclassify the [device](/usc/21/321.md?p=h-1) 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](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=h-1) 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](/usc/21/321.md?p=d), upon his own initiative or upon petition of an interested [person](/usc/21/321.md?p=e) 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](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=b) of a [device](/usc/21/321.md?p=h-1) which conforms to such standard without the change or changes provided by such proposed amendment.
  - (5)
    - (A) The [Secretary](/usc/21/321.md?p=d)—
      - (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](/usc/21/321.md?p=e) 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](/usc/21/360fff.md?p=1) of experts, established pursuant to [subparagraph (B)](#b-5-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](/usc/21/360fff.md?p=1), the [Secretary](/usc/21/321.md?p=d) shall provide the [advisory committee](/usc/21/360fff.md?p=1) with the data and information on which such proposed regulation is based. The [advisory committee](/usc/21/360fff.md?p=1) 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](/usc/21/321.md?p=d) and other data and information before it, submit to the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=d).

    - (B) The [Secretary](/usc/21/321.md?p=d) shall establish [advisory committees](/usc/21/360fff.md?p=1) (which may not be panels under [section 360c of this title](/usc/21/360c.md)) to receive referrals under [subparagraph (A)](#b-5-A). The [Secretary](/usc/21/321.md?p=d) shall appoint as members of any such [advisory committee](/usc/21/360fff.md?p=1) [persons](/usc/21/321.md?p=e) qualified in the subject matter to be referred to the committee and of appropriately diversified professional background, except that the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=h-1) manufacturing industry. Members of an [advisory committee](/usc/21/360fff.md?p=1) 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](/usc/21/321.md?p=d), shall be entitled to receive compensation at rates to be fixed by the [Secretary](/usc/21/321.md?p=d), 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](/usc/21/360eee.md?p=2) by [section 5703 of title 5](/usc/5/5703.md) for [persons](/usc/21/321.md?p=e) in the Government service employed intermittently. The [Secretary](/usc/21/321.md?p=d) shall designate one of the members of each [advisory committee](/usc/21/360fff.md?p=1) to serve as chairman thereof. The [Secretary](/usc/21/321.md?p=d) shall furnish each [advisory committee](/usc/21/360fff.md?p=1) 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)](#b-5-A).
- (c) **Recognition of standard—**
  - (1)
    - (A) In addition to establishing a performance standard under this section, the [Secretary](/usc/21/321.md?p=d) shall, by publication in the Federal Register (or, with respect to a susceptibility test interpretive criteria standard under [section 360a–2 of this title](/usc/21/360a–2.md), by posting on the Interpretive Criteria Website in accordance with such section), recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a [person](/usc/21/321.md?p=e) 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](/usc/21/321.md?p=e) elects to use a standard recognized by the [Secretary](/usc/21/321.md?p=d) under [subparagraph (A)](#c-1-A) to meet the requirements described in such subparagraph, the [person](/usc/21/321.md?p=e) shall provide a declaration of conformity to the [Secretary](/usc/21/321.md?p=d) that certifies that the [device](/usc/21/321.md?p=h-1) is in conformity with such standard. A [person](/usc/21/321.md?p=e) may elect to use data, or information, other than data required by a standard recognized under [subparagraph (A)](#c-1-A) to meet any requirement regarding [devices](/usc/21/321.md?p=h-1) under this chapter.
    - (C)
      - (i) Any [person](/usc/21/321.md?p=e) may submit a request for recognition under [subparagraph (A)](#c-1-A) of all or part of an appropriate standard established by a nationally or internationally recognized standard organization.[^1]
      - (ii) Not later than 60 calendar days after the [Secretary](/usc/21/321.md?p=d) receives such a request, the [Secretary](/usc/21/321.md?p=d) shall—
        - (I) make a determination to recognize all, part, or none of the standard that is the subject of the request; and
        - (II) issue to the [person](/usc/21/321.md?p=e) who submitted such request a response in writing that [states](/usc/21/321.md?p=a-1) the [Secretary](/usc/21/321.md?p=d)’s rationale for that determination, including the scientific, technical, regulatory, or other basis for such determination.
      - (iii) The [Secretary](/usc/21/321.md?p=d) shall make a response issued under [clause (ii)(II)](#c-1-C-ii-II) publicly available, in such a manner as the [Secretary](/usc/21/321.md?p=d) determines appropriate.
      - (iv) The [Secretary](/usc/21/321.md?p=d) shall take such actions as may be necessary to implement all or part of a standard recognized under [clause (ii)(I)](#c-1-C-ii-I), in accordance with [subparagraph (A)](#c-1-A).
    - (D) The [Secretary](/usc/21/321.md?p=d) shall make publicly available, in such manner as the [Secretary](/usc/21/321.md?p=d) determines appropriate, the rationale for recognition under [subparagraph (A)](#c-1-A) of all, part, or none of a standard, including the scientific, technical, regulatory, or other basis for the decision regarding such recognition.
  - (2) The [Secretary](/usc/21/321.md?p=d) may withdraw such recognition of a standard through publication of a notice in the Federal Register if the [Secretary](/usc/21/321.md?p=d) determines that the standard is no longer appropriate for meeting a requirement regarding [devices](/usc/21/321.md?p=h-1) under this chapter.
  - (3)
    - (A) Subject to [subparagraph (B)](#c-3-B), the [Secretary](/usc/21/321.md?p=d) shall accept a declaration of conformity that a [device](/usc/21/321.md?p=h-1) is in conformity with a standard recognized under [paragraph (1)](#c-1) unless the [Secretary](/usc/21/321.md?p=d) finds—
      - (i) that the data or information submitted to support such declaration does not demonstrate that the [device](/usc/21/321.md?p=h-1) 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](/usc/21/321.md?p=h-1) under review.
    - (B) The [Secretary](/usc/21/321.md?p=d) may request, at any time, the data or information relied on by the [person](/usc/21/321.md?p=e) to make a declaration of conformity with respect to a standard recognized under [paragraph (1)](#c-1).
    - (C) A [person](/usc/21/321.md?p=e) making a declaration of conformity with respect to a standard recognized under [paragraph (1)](#c-1) shall maintain the data and information demonstrating conformity of the [device](/usc/21/321.md?p=h-1) to the standard for a period of two years after the date of the classification or approval of the [device](/usc/21/321.md?p=h-1) by the [Secretary](/usc/21/321.md?p=d) or a period equal to the expected design life of the [device](/usc/21/321.md?p=h-1), whichever is longer.
  - (4) The [Secretary](/usc/21/321.md?p=d) shall provide to all employees of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration who review premarket submissions for [devices](/usc/21/321.md?p=h-1) periodic training on the concept and use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement under this chapter, including standards relevant to an employee’s area of [device](/usc/21/321.md?p=h-1) review.
- (d) **Accreditation scheme for conformity assessment—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall establish a program under which—
    - (A) testing laboratories meeting criteria specified in guidance by the [Secretary](/usc/21/321.md?p=d) may be accredited, by accreditation bodies meeting criteria specified in guidance by the [Secretary](/usc/21/321.md?p=d), to conduct testing to support the assessment of the conformity of a [device](/usc/21/321.md?p=h-1) to certain standards recognized under this section; and
    - (B) subject to [paragraph (2)](#d-2), results from tests conducted to support the assessment of conformity of [devices](/usc/21/321.md?p=h-1) as described in [subparagraph (A)](#d-1-A) conducted by testing laboratories accredited pursuant to this subsection shall be accepted by the [Secretary](/usc/21/321.md?p=d) for purposes of demonstrating such conformity unless the [Secretary](/usc/21/321.md?p=d) finds that certain results of such tests should not be so accepted.
  - (2) **Secretarial review of accredited laboratory results—** The [Secretary](/usc/21/321.md?p=d) may—
    - (A) review the results of tests conducted by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such results or of the processes of accredited bodies or testing laboratories;
    - (B) following such review, take additional measures under this chapter, as the [Secretary](/usc/21/321.md?p=d) determines appropriate, such as—
      - (i) suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under [paragraph (1)(A)](#d-1-A); or
      - (ii) requesting additional information with respect to a [device](/usc/21/321.md?p=h-1); and
    - (C) if the [Secretary](/usc/21/321.md?p=d) becomes aware of information materially bearing on the safety or effectiveness of a [device](/usc/21/321.md?p=h-1) for which an assessment of conformity was supported by testing conducted by a testing laboratory accredited under this subsection, take such additional measures under this chapter, as the [Secretary](/usc/21/321.md?p=d) determines appropriate, such as—
      - (i) suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under [paragraph (1)(A)](#d-1-A); or
      - (ii) requesting additional information with regard to such [device](/usc/21/321.md?p=h-1).
  - (3) **Report—** The [Secretary](/usc/21/321.md?p=d) shall make available on the internet website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration an annual report on the progress of the program under this subsection.

## Footnotes

[^1]: So in original. Probably should be “standard development organization.”

## Source credit

(June 25, 1938, ch. 675, § 514, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 546; amended Pub. L. 94–460, title III, § 304, Oct. 8, 1976, 90 Stat. 1960; Pub. L. 101–629, §§ 6(a), (b)(1), 18(b), Nov. 28, 1990, 104 Stat. 4519, 4528; Pub. L. 102–300, § 6(g), June 16, 1992, 106 Stat. 241; Pub. L. 103–80, § 4(a)(1), Aug. 13, 1993, 107 Stat. 779; Pub. L. 105–115, title II, § 204(a), (d), Nov. 21, 1997, 111 Stat. 2335, 2336; Pub. L. 112–144, title VI, § 608(a)(2)(B), July 9, 2012, 126 Stat. 1056; Pub. L. 114–255, div. A, title III, §§ 3044(b)(3), 3053(a), Dec. 13, 2016, 130 Stat. 1121, 1125; Pub. L. 115–52, title II, § 205(a), Aug. 18, 2017, 131 Stat. 1016; Pub. L. 117–180, div. F, title II, § 2005, Sept. 30, 2022, 136 Stat. 2153.)

## Notes

### Editorial Notes

### Amendments

2022—Subsec. (d). Pub. L. 117–180 amended subsec. (d) generally. Prior to amendment, subsec. (d) related to a pilot program for accrediting laboratories to assess device conformance.

2017—Subsec. (d). Pub. L. 115–52 added subsec. (d).

2016—Subsec. (c)(1)(A). Pub. L. 114–255, § 3044(b)(3), inserted “(or, with respect to a susceptibility test interpretive criteria standard under section 360a–2 of this title, by posting on the Interpretive Criteria Website in accordance with such section)” after “the Secretary shall, by publication in the Federal Register”.

Subsec. (c)(1)(C), (D). Pub. L. 114–255, § 3053(a)(1), added subpars. (C) and (D).

Subsec. (c)(4). Pub. L. 114–255, § 3053(a)(2), added par. (4).

2012—Subsec. (a)(1). Pub. L. 112–144 substituted “under an administrative order under section 360c(e) of this title (or a regulation promulgated under such section prior to July 9, 2012) but such order (or regulation)” for “under a regulation under section 360c(e) of this title but such regulation”.

1997—Subsec. (a)(1). Pub. L. 105–115, § 204(d)(1), substituted “under subsection (b)” for “under this section”.

Subsec. (a)(2). Pub. L. 105–115, § 204(d)(2), substituted “under subsection (b)” for “under this section” in introductory provisions.

Subsec. (a)(3). Pub. L. 105–115, § 204(d)(3), substituted “under subsection (b)” for “under this section”.

Subsec. (a)(4). Pub. L. 105–115, § 204(d)(4), substituted “this subsection and subsection (b)” for “this section” in introductory provisions.

Subsec. (c). Pub. L. 105–115, § 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, § 18(b), identical to amendment by Pub. L. 102–300, § 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, § 18(b)(1), (2). See 1990 Amendment note below.

1990—Subsec. (a)(1). Pub. L. 101–629, § 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, § 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, § 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, § 6(b)(1)(A), substituted “paragraph (1)” for “paragraph (2)”.

Subsec. (b)(4)(A). Pub. L. 101–629, § 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, § 18(b)(1), as amended by Pub. L. 102–300, § 6(g)(1), (2), and Pub. L. 103–80, § 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, § 18(b)(2), as amended by Pub. L. 102–300, § 6(g)(1), (3), and Pub. L. 103–80, § 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, § 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, § 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).

### Statutory Notes and Related Subsidiaries

### Effective Date of 2022 Amendment

Pub. L. 117–180, div. F, title II, § 2008, Sept. 30, 2022, 136 Stat. 2154, provided that: “The amendments made by this title [amending this section and sections 360m and 379i to 379j–1 of this title and repealing provisions set out as notes under sections 379i and 379j–1 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.) shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after October 1, 2022, regardless of the date of the enactment of this Act.”

### Effective Date of 2017 Amendment

Amendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 3 of part C of subchapter VII of this chapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

### 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.

### Construction of 2016 Amendment

Nothing in amendment by section 3044(b)(3) of Pub. L. 114–255 to be construed to restrict the prescribing of antimicrobial drugs or other products, including drugs approved under section 356(h) of this title, by health care professionals, or to limit the practice of health care, see section 3043 of Pub. L. 114–255, set out as a note under section 356 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 1013 of Title 5, Government Organization and Employees.

### Guidance

Pub. L. 114–255, div. A, title III, § 3053(b), Dec. 13, 2016, 130 Stat. 1125, provided that: “The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall review and update, if necessary, previously published guidance and standard operating procedures identifying the principles for recognizing standards, and for withdrawing the recognition of standards, under section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking into account the experience with and reliance on a standard by foreign regulatory authorities and the device industry, and whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices.”

### 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, § 101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.