21 USC 360 - General provisions respecting control of devices intended for human use

1 See Delayed Applicability of Amendment note below.

The sponsor of a device for which submission of an application for an investigational device exemption is required shall submit to the Secretary in such application a diversity action plan for clinical studies of the device, in the form and manner specified in guidance issued by the Secretary.

2 So in original. Probably should be “The term ‘device’,”.

as defined in

3 So in original. Probably should be “sections”.

315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or

Delayed Applicability of Amendment

For provisions related to delayed applicability of subsection (g)(9) of this section as added by section 3601(span) of Puspan. L. 117–328, see Effective Date of 2022 Amendment note set out under section 355 of this title.

Editorial Notes

References in Text

July 9, 2012, referred to in subsec. (span)(3), was in the original “the date of enactment of this section”, which was translated as meaning the date of enactment of Puspan. L. 112–144, which amended subsec. (span) generally, to reflect the probable intent of Congress.

Section 709(span) of the FDA Reauthorization Act of 2017, referred to in subsec. (q)(2), is section 709(span) of Puspan. L. 115–52, which is set out as a note below.

Codification

In subsec. (k), “section 3324(a) and (span) of title 31 and section 6101 of title 41” substituted for “sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5)” on authority of Puspan. L. 97–258, § 4(span), Sept. 13, 1982, 96 Stat. 1067, which Act enacted Title 31, Money and Finance, and Puspan. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Amendments

2022—Subsec. (f)(3). Puspan. L. 117–286 substituted “Section 1013 of title 5” for “Section 14 of the Federal Advisory Committee Act” in concluding provisions.

Subsec. (g)(9). Puspan. L. 117–328, § 3601(span), added par. (9).

Subsec. (m)(6)(A)(iv). Puspan. L. 117–328, § 3103, substituted “October 1, 2027” for “December 24, 2022”.

Puspan. L. 117–229 substituted “December 24, 2022” for “December 17, 2022”.

Puspan. L. 117–180 substituted “December 17” for “October 1”.

2017—Subsec. (m)(4). Puspan. L. 115–52, § 502(span)(1)(B), inserted “or an appropriate local committee” after “review committee” in two places in concluding provisions.

Subsec. (m)(4)(B). Puspan. L. 115–52, § 502(span)(1)(A), inserted “or an appropriate local committee” after “review committee” in two places.

Subsec. (m)(6)(A)(iv). Puspan. L. 115–52, § 502(span)(2), substituted “2022” for “2017”.

Subsec. (p). Puspan. L. 115–52, § 706(a), added subsec. (p).

Subsec. (q). Puspan. L. 115–52, § 709(a), added subsec. (q). Amendment was executed to this section as amended by section 706(a) of Puspan. L. 115–52, notwithstanding directory language referring to section as amended by section 708 of Puspan. L. 115–52, which did not amend this section.

2016—Subsec. (g)(3). Puspan. L. 114–255, § 3024(a)(2), substituted “subparagraph (D)(ii)” for “subparagraph (D)” in concluding provisions.

Subsec. (g)(3)(A)(i). Puspan. L. 114–255, § 3056(1)(A), struck out “local” before “institutional review committee” and “which has been” before “established in accordance with”.

Subsec. (g)(3)(B). Puspan. L. 114–255, § 3056(1)(B), substituted “an institutional” for “a local institutional”.

Subsec. (g)(3)(D). Puspan. L. 114–255, § 3024(a)(1), substituted “except where, subject to such conditions as the Secretary may prescribe—” for “except where subject to such conditions as the Secretary may prescribe,”, added cl. (i), and inserted cl. (ii) designation before “the investigator”.

Subsec. (h)(4)(A). Puspan. L. 114–255, § 3038(span)(1), substituted “Subject to subparagraph (C), any information” for “Any information” in introductory provisions.

Subsec. (h)(4)(C). Puspan. L. 114–255, § 3038(span)(2), added subpar. (C).

Subsec. (m)(1). Puspan. L. 114–255, § 3052(a)(1), substituted “not more than 8,000” for “fewer than 4,000”.

Subsec. (m)(2)(A). Puspan. L. 114–255, § 3052(a)(2), substituted “not more than 8,000” for “fewer than 4,000”.

Subsec. (m)(4). Puspan. L. 114–255, § 3056(2)(C), struck out “local” after “chairperson of the” in concluding provisions.

Subsec. (m)(4)(A). Puspan. L. 114–255, § 3056(2)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: “in facilities that have established, in accordance with regulations of the Secretary, a local institutional review committee to supervise clinical testing of devices in the facilities, and”.

Subsec. (m)(4)(B). Puspan. L. 114–255, § 3056(2)(B), substituted “an institutional” for “a local institutional”.

Subsec. (m)(6)(A)(ii). Puspan. L. 114–255, § 3052(a)(3), substituted “8,000” for “4,000”.

Subsec. (o). Puspan. L. 114–255, § 3060(a), added subsec. (o).

2012—Subsec. (span). Puspan. L. 112–144, § 617, amended subsec. (span) generally. Prior to amendment, subsec. (span) related to custom devices.

Subsec. (g)(2)(B)(ii). Puspan. L. 112–144, § 601(1), inserted “safety or effectiveness” before “data obtained”.

Subsec. (g)(4)(C). Puspan. L. 112–144, § 601(2), added subpar. (C).

Subsec. (g)(8). Puspan. L. 112–144, § 606, added par. (8).

Subsec. (m)(6)(A)(i). Puspan. L. 112–144, § 613(a)(1)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows:

“(i)(I) The device with respect to which the exemption is granted is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs.

“(II) The device was not previously approved under this subsection for the pediatric patients or the pediatric subpopulation described in subclause (I) prior to September 27, 2007.”

Subsec. (m)(6)(A)(ii). Puspan. L. 112–144, § 613(a)(1)(A)(ii), added cl. (ii) and struck out former cl. (ii) which read as follows: “During any calendar year, the number of such devices distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary grants such exemption. The annual distribution number shall be based on the number of individuals affected by the disease or condition that such device is intended to treat, diagnose, or cure, and of that number, the number of individuals likely to use the device, and the number of devices reasonably necessary to treat such individuals. In no case shall the annual distribution number exceed the number identified in paragraph (2)(A).”

Subsec. (m)(6)(A)(iv). Puspan. L. 112–144, § 507(c), substituted “2017” for “2012”.

Subsec. (m)(6)(C). Puspan. L. 112–144, § 613(a)(1)(B), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “A person may petition the Secretary to modify the annual distribution number specified by the Secretary under subparagraph (A)(ii) with respect to a device if additional information on the number of individuals affected by the disease or condition arises, and the Secretary may modify such number but in no case shall the annual distribution number exceed the number identified in paragraph (2)(A).”

Subsec. (m)(7). Puspan. L. 112–144, § 613(a)(2), substituted “regarding a device described in paragraph (6)(A)(i)(I)” for “regarding a device”.

Subsec. (m)(8). Puspan. L. 112–144, § 613(a)(3), substituted “of all devices described in paragraph (6)(A)(i)(I)” for “of all devices described in paragraph (6)”.

2007—Subsec. (m)(2). Puspan. L. 110–85, § 801(span)(3)(E), inserted before period at end of first sentence of concluding provisions “and such application shall include the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application)”.

Subsec. (m)(3). Puspan. L. 110–85, § 303(a)(1), substituted “Except as provided in paragraph (6), no” for “No”.

Subsec. (m)(5). Puspan. L. 110–85, § 303(a)(2), inserted “, if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met,” after “public health” and inserted at end “If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing.”

Subsec. (m)(6) to (8). Puspan. L. 110–85, § 303(a)(3), added pars. (6) to (8) and struck out former par. (6) which read as follows: “The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing.”

2005—Subsec. (n). Puspan. L. 109–96 added subsec. (n).

1997—Subsec. (f)(1)(B)(iii). Puspan. L. 105–115, § 410(a), added cl. (iii).

Subsec. (g)(6), (7). Puspan. L. 105–115, § 201(a), added pars. (6) and (7).

Subsec. (h)(4). Puspan. L. 105–115, § 216(a)(1), amended par. (4) generally. Prior to amendment, par. (4) related to premarket approval of devices.

Subsec. (l). Puspan. L. 105–115, § 125(span)(2)(E), struck out “or antibiotic drugs” after “new drugs” in span.

Subsec. (l)(4). Puspan. L. 105–115, § 125(span)(2)(E), struck out par. (4) which read as follows: “Any device intended for human use which on the enactment date was subject to the requirements of section 357 of this title shall be subject to such requirements as follows:

“(A) In the case of such a device which is classified into class I, such requirements shall apply to such device until the effective date of the regulation classifying the device into such class.

“(B) In the case of such a device which is classified into class II, such requirements shall apply to such device until the effective date of a performance standard applicable to the device under section 360d of this title.

“(C) In the case of such a device which is classified into class III, such requirements shall apply to such device until the date on which the device is required to have in effect an approved application under section 360e of this title.”

Subsec. (m)(2). Puspan. L. 105–115, § 203(1), inserted at end “The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.”

Subsec. (m)(4). Puspan. L. 105–115, § 203(2)(B), inserted at end “In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.”

Subsec. (m)(4)(B). Puspan. L. 105–115, § 203(2)(A), inserted before period at end “, unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient”.

Subsec. (m)(5). Puspan. L. 105–115, § 203(3), amended par. (5) generally. Prior to amendment, par. (5) read as follows: “An exemption under paragraph (2) shall be for a term of 18 months and may only be initially granted in the 5-year period beginning on the date regulations under paragraph (6) take effect. The Secretary may extend such an exemption for a period of 18 months if the Secretary is able to make the findings set forth in paragraph (2) and if the applicant supplies information demonstrating compliance with paragraph (3). An exemption may be extended more than once and may be extended after the expiration of such 5-year period.”

Subsec. (m)(6). Puspan. L. 105–115, § 203(4), amended par. (6) generally. Prior to amendment, par. (6) read as follows: “Within one year of November 28, 1990, the Secretary shall issue regulations to implement this subsection.”

1992—Subsec. (g)(2)(A). Puspan. L. 102–571 substituted “379e” for “376”.

1990—Subsec. (c). Puspan. L. 101–629, § 11(1), substituted “from class III to class II or class I” for “under section 360c of this title from class III to class II” and inserted “(1) in accordance with subsection (h), and (2)” after “except”.

Subsec. (f)(1)(A). Puspan. L. 101–629, § 18(e), inserted “pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device),” after “manufacture,”.

Subsec. (h)(3). Puspan. L. 101–629, § 11(2)(A), substituted “Except as provided in paragraph (4), any” for “Any”.

Subsec. (h)(4). Puspan. L. 101–629, § 11(2)(B), added par. (4).

Subsec. (i). Puspan. L. 101–629, § 6(span)(2), substituted “section 360d(span)(5)(B)” for “section 360d(g)(5)(B)”.

Subsec. (j). Puspan. L. 101–629, § 3(span)(2), substituted “Except as provided in section 360i(e) of this title, no” for “No”.

Subsec. (l)(2). Puspan. L. 101–629, § 18(f), struck out “and after affording the petitioner an opportunity for an informal hearing” after “under this paragraph”.

Puspan. L. 101–629, § 5(c)(2), 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. (l)(5). Puspan. L. 101–629, § 4(span)(2), added par. (5).

Subsec. (m). Puspan. L. 101–629, § 14(a), added subsec. (m).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Subsec. (g)(9) of this section, as added by section 3601(span) of Puspan. L. 117–328, applicable only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guidance required under section 3602 of Puspan. L. 117–328, see section 3602(c) of Puspan. L. 117–328, set out as a note under section 355 of this title.

Effective Date of 1997 Amendment

Amendment by sections 201(a), 203, 216(a)(1), and 410(a) of 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.

Effective Date of 1990 Amendment

Puspan. L. 101–629, § 14(span), Nov. 28, 1990, 104 Stat. 4525, provided that: “Subsection (m) of section 520 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360j(m)], as added by the amendment made by subsection (a), shall take effect on the effective date of the regulations issued by the Secretary under paragraph (6) of such subsection.”

Regulations and Guidance Concerning Over-the-Counter Hearing Aids

Puspan. L. 115–52, title VII, § 709(span), (c), Aug. 18, 2017, 131 Stat. 1066, 1067, provided that:

“(span)Regulations To Establish Category.—

“(1)In general.—The Secretary of Health and Human Services (referred to in this section [amending this section and enacting this note] as the ‘Secretary’), not later than 3 years after the date of enactment of this Act [Aug. 18, 2017], shall promulgate proposed regulations to establish a category of over-the-counter hearing aids, as defined in subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) as amended by subsection (a), and, not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.

“(2)Requirements.—In promulgating the regulations under paragraph (1), the Secretary shall—

“(A) include requirements that provide reasonable assurances of the safety and effectiveness of over-the-counter hearing aids;

“(B) include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids;

“(C) include requirements for appropriate labeling of over-the-counter hearing aids, including requirements that such labeling include a conspicuous statement that the device is only intended for adults age 18 and older, information on how consumers may report adverse events, information on any contraindications, conditions, or symptoms of medically treatable causes of hearing loss, and advisements to consult promptly with a licensed health care practitioner; and

“(D) describe the requirements under which the sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.

“(3)Premarket notification.—The Secretary shall make findings under section 510(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j[(q)]), as amended by subsection (a)) require a report under section 510(k) [21 U.S.C. 360(k)] to provide reasonable assurance of safety and effectiveness.

“(4)Effect on state law.—No State or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j[(q)]), as amended by subsection (a)) through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids.

“(5)No effect on private remedies.—Nothing in this section shall be construed to modify or otherwise affect the ability of any person to exercise a private right of action under any State or Federal product liability, tort, warranty, contract, or consumer protection law.

“(c)New Guidance Issued.—Not later than the date on which final regulations are issued under subsection (span), the Secretary shall update and finalize the draft guidance of the Department of Health and Human Services entitled ‘Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products’, issued on November 7, 2013. Such updated and finalized guidance shall clarify which products, on the basis of claims or other marketing, advertising, or labeling material, meet the definition of a device in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and which products meet the definition of a personal sound amplification product, as set forth in such guidance.”

Guidance Document on Probable Benefit

Puspan. L. 114–255, div. A, title III, § 3052(span), Dec. 13, 2016, 130 Stat. 1125, provided that: “Not later than 18 months after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that defines the criteria for establishing ‘probable benefit’ as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C)).”

Reports

Puspan. L. 114–255, div. A, title III, § 3060(span), Dec. 13, 2016, 130 Stat. 1132, provided that: “The Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’), after consultation with agencies and offices of the Department of Health and Human Services involved in health information technology, shall publish a report, not later than 2 years after the date of enactment of this Act [Dec. 13, 2016] and every 2 years thereafter, that—

“(1) includes input from outside experts, such as representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary;

“(2) examines information available to the Secretary on any risks and benefits to health associated with software functions described in section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j[(o)(1)]) (as amended by subsection (a)); and

“(3) summarizes findings regarding the impact of such software functions on patient safety, including best practices to promote safety, education, and competency related to such functions.”

Applicability to Existing Devices

Puspan. L. 112–144, title VI, § 613(span), July 9, 2012, 126 Stat. 1061, provided that: “A sponsor of a device for which an exemption was approved under paragraph (2) of section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before the date of enactment of this Act [July 9, 2012] may seek a determination under subclause (I) or (II) of section 520(m)(6)(A)(i) (as amended by subsection (a)). If the Secretary of Health and Human Services determines that such subclause (I) or (II) applies with respect to a device, clauses (ii), (iii), and (iv) of subparagraph (A) and subparagraphs (B), (C), (D), and (E) of paragraph (6) of such section 520(m) shall apply to such device, and the Secretary shall determine the annual distribution number for purposes of clause (ii) of such subparagraph (A) when making the determination under this subsection.”

Guidance

Puspan. L. 110–85, title III, § 303(c), Sept. 27, 2007, 121 Stat. 862, provided that: “Not later than 180 days after the date of the enactment of this Act [Sept. 27, 2007], the Commissioner of Food and Drugs shall issue guidance for institutional review committees on how to evaluate requests for approval for devices for which a humanitarian device exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted.”

Puspan. L. 107–250, title II, § 213, Oct. 26, 2002, 116 Stat. 1614, provided that: “Not later than 270 days after the date of the enactment of this Act [Oct. 26, 2002], the Secretary of Health and Human Services shall issue guidance on the following:

“(1) The type of information necessary to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in pediatric populations.

“(2) Protections for pediatric subjects in clinical investigations of the safety or effectiveness of such devices.”

Report on Humanitarian Device Exemptions

Puspan. L. 101–629, § 14(c), Nov. 28, 1990, 104 Stat. 4525, directed Secretary of Health and Human Services, within 4 years after issuance of regulations under 21 U.S.C. 360j(m)(6), to report to Congress on types of devices exempted, an evaluation of effects of such section, and a recommendation on extension of the section.

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.