21 USC 360 - Classification of devices intended for human use

1 So in original. The word “the” probably should not appear.

chapter 10 of title 5.

Editorial Notes

Amendments

2022—Subsec. (span)(1). Puspan. L. 117–286, § 4(a)(155)(A), substituted “Section 1013 of title 5” for “Section 14 of the Federal Advisory Committee Act” in concluding provisions.

Subsec. (span)(8). Puspan. L. 117–286, § 4(a)(155)(B), substituted “chapter 10 of title 5.” for “Federal Advisory Committee Act.”

Subsec. (k). Puspan. L. 117–328 added subsec. (k).

2017—Subsec. (span)(5)(D). Puspan. L. 115–52, § 901(h), substituted “medical devices that may be specifically the subject of a review by a classification panel” for “medical device submissions”.

Subsec. (span)(9). Puspan. L. 115–52, § 707(span), struck out par. (9) which read as follows: “The Secretary shall classify an accessory under this section based on the intended use of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used.”

Subsec. (f)(6). Puspan. L. 115–52, § 707(a), added par. (6).

2016—Subsec. (span)(5). Puspan. L. 114–255, § 3055(a), designated existing provisions as subpar. (A) and added subpars. (B) to (D).

Subsec. (span)(6)(A)(iii). Puspan. L. 114–255, § 3055(span)(1), inserted before period at end “, including, subject to the discretion of the panel chairperson, by designating a representative who will be provided a time during the panel meeting to address the panel for the purpose of correcting misstatements of fact or providing clarifying information, and permitting the person or representative to call on experts within the person’s organization to address such specific issues in the time provided”.

Subsec. (span)(6)(B). Puspan. L. 114–255, § 3055(span)(2), added subpar. (B) and struck out former subpar. (B) which read as follows: “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.”

Subsec. (span)(9). Puspan. L. 114–255, § 3060(c), added par. (9).

Subsec. (f)(2)(A)(i). Puspan. L. 114–255, § 3101(a)(2)(I)(i), struck out “within 30 days” after “may request,”.

Subsec. (f)(2)(A)(iv). Puspan. L. 114–255, § 3101(a)(2)(I)(ii), substituted “low to moderate” for “low-moderate”.

Subsec. (j). Puspan. L. 114–255, § 3058(a), added subsec. (j).

2012—Subsec. (a)(3)(D)(iii) to (v). Puspan. L. 112–144, § 602(a), added cls. (iii) and (iv) and redesignated former cl. (iii) as (v).

Subsec. (e)(1). Puspan. L. 112–144, § 608(a)(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “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.”

Subsec. (e)(2). Puspan. L. 112–144, § 608(a)(2)(A), substituted “an order issued” for “regulation promulgated” in introductory provisions.

Subsec. (f)(1)(C). Puspan. L. 112–144, § 607(span), added subpar. (C).

Subsec. (f)(2)(A). Puspan. L. 112–144, § 607(a)(1)–(3), designated existing provisions as cl. (i), struck out “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” before period at end, and added cls. (ii) to (v).

Subsec. (f)(2)(B)(i). Puspan. L. 112–144, § 607(a)(4), substituted “The Secretary” for “Not later than 60 days after the date of the submission of the request under subparagraph (A), the Secretary”.

Subsec. (i)(1)(D). Puspan. L. 112–144, § 602(span), designated existing provisions as cl. (i) and added cls. (ii) and (iii).

2002—Subsec. (i)(1)(E)(iv). Puspan. L. 107–250 struck out cl. (iv) which read as follows: “This subparagraph has no legal effect after the expiration of the five-year period beginning on November 21, 1997.”

1997—Subsec. (a)(3)(A). Puspan. L. 105–115, § 217, substituted “1 or more clinical investigations” for “clinical investigations”.

Subsec. (a)(3)(C), (D). Puspan. L. 105–115, § 205(a), added subpars. (C) and (D).

Subsec. (span)(5) to (8). Puspan. L. 105–115, § 208, added pars. (5) to (8).

Subsec. (f)(1). Puspan. L. 105–115, § 207(1)(B), substituted “paragraph (2) or (3)” for “paragraph (2)” in closing provisions.

Subsec. (f)(1)(B). Puspan. L. 105–115, § 207(1)(A), substituted “paragraph (3)” for “paragraph (2)”.

Subsec. (f)(2) to (4). Puspan. L. 105–115, § 207(2), (3), added par. (2) and redesignated former pars. (2) and (3) as (3) and (4), respectively.

Subsec. (f)(5). Puspan. L. 105–115, § 206(span), added par. (5).

Subsec. (i)(1)(A)(ii). Puspan. L. 105–115, § 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). Puspan. L. 105–115, § 205(span), added subpars. (C) to (E).

Subsec. (i)(1)(F). Puspan. L. 105–115, § 206(c)(2), added subpar. (F).

1993—Subsec. (span)(3). Puspan. L. 103–80 substituted “5703” for “5703(span)”.

1992—Subsec. (f)(3). Puspan. 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). Puspan. L. 101–629, § 5(a)(1), substituted “or to establish special controls” for “or to establish a performance standard”.

Subsec. (a)(1)(B). Puspan. L. 101–629, § 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). Puspan. L. 101–629, § 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). Puspan. L. 101–629, § 5(span), designated existing provisions as par. (1), redesignated cls. (1) and (2) as (A) and (B), respectively, and added par. (2).

Subsec. (f). Puspan. L. 101–629, § 5(c)(3), inserted “and reclassification” before “of” in span.

Subsec. (f)(2)(A). Puspan. L. 101–629, § 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). Puspan. L. 101–629, § 18(a), substituted “the Secretary may for good cause shown” for “the Secretary shall”.

Subsec. (f)(3). Puspan. L. 101–629, § 4(a), added par. (3).

Subsec. (i). Puspan. L. 101–629, § 12(a), added subsec. (i).

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

Puspan. L. 115–52, title VII, § 707(c), Aug. 18, 2017, 131 Stat. 1062, provided that: “The amendments made by subsections (a) and (span) [amending this section] shall take effect on the date that is 60 days after the date of enactment of this Act [Aug. 18, 2017].”

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.

Short Title of 1976 Amendment

Puspan. L. 94–295, § 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

Puspan. L. 101–629, § 12(span), Nov. 28, 1990, 104 Stat. 4524, 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).”

Devices Reclassified Prior to July 9, 2012

Puspan. L. 112–144, title VI, § 608(a)(3), July 9, 2012, 126 Stat. 1056, provided that:

“(A)In general.—The amendments made by this subsection [amending this section and sections 360d and 360g of this title] shall have no effect on a regulation promulgated with respect to the classification of a device under section 513(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360c(e)] prior to the date of enactment of this Act [July 9, 2012].

“(B)Applicability of other provisions.—In the case of a device reclassified under section 513(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360c(e)] by regulation prior to the date of enactment of this Act [July 9, 2012], section 517(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1)) shall apply to such regulation promulgated under section 513(e) of such Act with respect to such device in the same manner such section 517(a)(1) applies to an administrative order issued with respect to a device reclassified after the date of enactment of this Act.”

Daily Wear Soft or Daily Wear Nonhydrophilic Plastic Contact Lenses

Puspan. L. 101–629, § 4(span)(3), Nov. 28, 1990, 104 Stat. 4517, 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, § 101(c)(1)] of Puspan. L. 101–509, set out in a note under section 5376 of Title 5.