21 USC 360 - Performance standards

1 So in original. Probably should be “standard development organization.”

Editorial Notes

Amendments

2022—Subsec. (d). Puspan. 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). Puspan. L. 115–52 added subsec. (d).

2016—Subsec. (c)(1)(A). Puspan. L. 114–255, § 3044(span)(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). Puspan. L. 114–255, § 3053(a)(1), added subpars. (C) and (D).

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

2012—Subsec. (a)(1). Puspan. 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). Puspan. L. 105–115, § 204(d)(1), substituted “under subsection (span)” for “under this section”.

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

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

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

Subsec. (c). Puspan. L. 105–115, § 204(a), added subsec. (c).

1993—Subsec. (span)(4)(B), (5)(A)(ii). Puspan. L. 103–80 amended directory language of Puspan. L. 101–619, § 18(span), identical to amendment by Puspan. L. 102–300, § 6(g)(1). See 1992 and 1990 Amendment notes below.

1992—Subsec. (span)(4)(B), (5)(A)(ii). Puspan. L. 102–300 made technical corrections to directory language of Puspan. L. 101–629, § 18(span)(1), (2). See 1990 Amendment note below.

1990—Subsec. (a)(1). Puspan. 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. (span). Puspan. L. 101–629, § 6(a)(2), (3), redesignated subsec. (g) as (span) and struck out former subsec. (span) 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. (span)(1), (2). Puspan. 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. (span)(3)(A)(i). Puspan. L. 101–629, § 6(span)(1)(A), substituted “paragraph (1)” for “paragraph (2)”.

Subsec. (span)(4)(A). Puspan. L. 101–629, § 6(span)(1)(B), substituted “paragraphs (1), (2), and (3)(B)” for “paragraphs (2) and (3)(B)”.

Subsec. (span)(4)(B). Puspan. L. 101–629, § 18(span)(1), as amended by Puspan. L. 102–300, § 6(g)(1), (2), and Puspan. L. 103–80, § 4(a)(1), struck out “, after affording all interested persons an opportunity for an informal hearing,” after “if he determines”.

Subsec. (span)(5)(A)(ii). Puspan. L. 101–629, § 18(span)(2), as amended by Puspan. L. 102–300, § 6(g)(1), (3), and Puspan. 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). Puspan. 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). Puspan. L. 101–629, § 6(a)(3), redesignated subsec. (g) as (span).

1976—Subsec. (a). Puspan. 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

Puspan. 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 Puspan. 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 Puspan. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 1997 Amendment

Amendment by Puspan. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Puspan. L. 105–115, set out as a note under section 321 of this title.

Construction of 2016 Amendment

Nothing in amendment by section 3044(span)(3) of Puspan. 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 Puspan. 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

Puspan. L. 114–255, div. A, title III, § 3053(span), 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 Puspan. L. 101–509, set out in a note under section 5376 of Title 5.