 So in original. Probably should be followed by a semicolon.

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

 So in original. The section number probably should not appear.

or section 360

Editorial Notes

References in Text

Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (i)(6)(B), is section 264(c) of Pub. L. 104–191, which is set out as a note under section 1320d–2 of Title 42, The Public Health and Welfare.

Amendments

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

2016—Subsec. (f). Pub. L. 114–255 substituted “or life sustaining” for “and life sustaining”.

2012—Subsec. (f). Pub. L. 112–144, § 614, substituted “Not later than December 31, 2012, the Secretary shall issue proposed” for “The Secretary shall promulgate” and inserted at end “The Secretary shall finalize the proposed regulations not later than 6 months after the close of the comment period and shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies.”

Subsec. (h). Pub. L. 112–144, § 615, added subsec. (h).

2007—Subsec. (a)(1)(B). Pub. L. 110–85, § 227, substituted “were to recur, which report under this subparagraph—” for “were to recur;” and added cls. (i) to (iii).

Subsecs. (f), (g). Pub. L. 110–85, § 226(a), added subsec. (f) and redesignated former subsec. (f) as (g).

1997—Subsec. (a). Pub. L. 105–115, § 213(a)(1)(A), (F), in introductory provisions, substituted “manufacturer or importer” for “manufacturer, importer, or distributor” and, in closing provisions, inserted at end “The Secretary shall by regulation require distributors to keep records and make such records available to the Secretary upon request. Paragraphs (4) and (8) apply to distributors to the same extent and in the same manner as such paragraphs apply to manufacturers and importers.”

Subsec. (a)(4). Pub. L. 105–115, § 213(a)(1)(B), substituted “manufacturer or importer” for “manufacturer, importer, or distributor”.

Subsec. (a)(7). Pub. L. 105–115, § 213(a)(1)(C), inserted “and” after semicolon at end.

Subsec. (a)(8). Pub. L. 105–115, § 213(a)(1)(D), substituted “manufacturer or importer” for “manufacturer, importer, or distributor” wherever appearing and substituted period for semicolon after “misbranded”.

Subsec. (a)(9). Pub. L. 105–115, § 213(a)(1)(E), struck out par. (9) which read as follows: “shall require distributors who submit such reports to submit copies of the reports to the manufacturer of the device for which the report was made.”

Subsec. (b)(1)(C). Pub. L. 105–115, § 213(c)(1)(A), in introductory provisions, substituted “on an annual basis” for “on a semi-annual basis” and struck out “and July 1” after “January 1” and struck out closing provisions which read as follows: “The Secretary may by regulation alter the frequency and timing of reports required by this subparagraph.”

Subsec. (b)(2)(A). Pub. L. 105–115, § 213(c)(1)(B)(i), inserted “or” after comma at end.

Subsec. (b)(2)(B). Pub. L. 105–115, § 213(c)(1)(B)(ii), substituted period for “, or” at end.

Subsec. (b)(2)(C). Pub. L. 105–115, § 213(c)(1)(B)(iii), struck out subpar. (C) which read as follows: “a disclosure required under subsection (a) of this section.”

Subsec. (b)(5), (6). Pub. L. 105–115, § 213(c)(2), added par. (5) and redesignated former par. (5) as (6).

Subsec. (d). Pub. L. 105–115, § 213(a)(2), struck out heading and text of subsec. (d). Text read as follows: “Each manufacturer, importer, and distributor required to make reports under subsection (a) of this section shall submit to the Secretary annually a statement certifying that—

“(1) the manufacturer, importer, or distributor did file a certain number of such reports, or

“(2) the manufacturer, importer, or distributor did not file any report under subsection (a) of this section.”

Subsec. (e). Pub. L. 105–115, § 211, amended heading and text of subsec. (e) generally. Prior to amendment, text read as follows: “Every person who registers under section 360 of this title and is engaged in the manufacture of—

“(1) a device the failure of which would be reasonably likely to have serious adverse health consequences and which is (A) a permanently implantable device, or (B) a life sustaining or life supporting device used outside a device user facility, or

“(2) any other device which the Secretary may designate,

shall adopt a method of device tracking.”

Subsec. (f)(1). Pub. L. 105–115, § 213(a)(3), substituted “or importer” for “, importer, or distributor” wherever appearing.

1993—Subsec. (a). Pub. L. 103–80 substituted “paragraph (7)” for “paragraph (4)” in last sentence.

1992—Subsec. (a). Pub. L. 102–300, § 5(a)(1), added pars. (1) to (3) and redesignated former pars. (1) to (6) as (4) to (9), respectively.

Subsec. (b)(1)(A). Pub. L. 102–300, § 5(a)(2)(A), substituted “a device has or may have” for “there is a probability that a device has”.

Subsec. (b)(1)(B). Pub. L. 102–300, § 5(a)(2)(A), (B), substituted “a device has or may have” for “there is a probability that a device has”, designated existing provisions as cl. (i), and added cl. (ii).

Subsec. (b)(5)(B)(iii). Pub. L. 102–300, § 5(a)(2)(C), struck out “immediate” before “medical”.

1990—Subsec. (a)(6). Pub. L. 101–629, § 3(a)(1), added par. (6).

Subsecs. (b), (c). Pub. L. 101–629, § 2(a), added subsec. (b) and redesignated former subsec. (b) as (c).

Subsecs. (d), (e). Pub. L. 101–629, § 3(b)(1), added subsecs. (d) and (e).

Subsec. (f). Pub. L. 101–629, § 7, added subsec. (f).

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

Effective Date of 1997 Amendment

Pub. L. 105–115, title II, § 211, Nov. 21, 1997, 111 Stat. 2345, provided in part that the amendment made by that section is effective 90 days after Nov. 21, 1997.

Amendment by section 213(a), (c) of 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.

Effective Date of 1992 Amendment

Pub. L. 102–300, § 2(b), June 16, 1992, 106 Stat. 238, provided that: “The amendments made by subsection (a) [amending sections 3(b)(3) and 3(c) of Pub. L. 101–629, set out as notes below] shall take effect as of May 27, 1992 and any rule to implement section 519(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(e)] proposed under section 3(c)(2) of the Safe Medical Devices Act of 1990 [Pub. L. 101–629, set out as a note below] shall revert to its proposed status as of such date.”

Pub. L. 102–300, § 5(b), June 16, 1992, 106 Stat. 240, provided that:

“The amendments made by subsection (a) [amending this section] shall take effect—

“(1)

1 year after the date of the enactment of this Act [June 16, 1992]; or

“(2)

on the effective date of regulations of the Secretary to implement such amendments,

whichever occurs first.”

Effective Date of 1990 Amendment

Pub. L. 101–629, § 2(c), Nov. 28, 1990, 104 Stat. 4513, provided that:

“Section 519(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)], as added by the amendment made by subsection (a), shall take effect—

“(1)

upon the effective date of regulations promulgated under subsection (b) [set out below], or

“(2)

upon the expiration of 12 months from the date of the enactment of this Act [Nov. 28, 1990],

whichever occurs first.”

Pub. L. 101–629, § 3(a)(2), Nov. 28, 1990, 104 Stat. 4514, provided that: “Section 519(a)(6) [21 U.S.C. 360i(a)(6)], as added by the amendment made by paragraph (1), shall take effect upon the effective date of final regulations under subsection (c) [set out below].”

Pub. L. 101–629, § 3(b)(3), Nov. 28, 1990, 104 Stat. 4514, as amended by Pub. L. 102–300, § 2(a)(1), June 16, 1992, 106 Stat. 238, provided that: “Section 519(e) [21 U.S.C. 360i(e)], as added by the amendment made by paragraph (1), shall take effect upon the expiration of 9 months after the issuance of final regulations under subsection (c) [set out below].”

[For effective date of amendment by Pub. L. 102–300, see section 2(b) of Pub. L. 102–300, set out above as an Effective Date of 1992 Amendment note.]

Regulations

Pub. L. 101–629, § 2(b), Nov. 28, 1990, 104 Stat. 4512, provided that: “The Secretary of Health and Human Services shall promulgate regulations to implement section 519(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)], as added by the amendment made by subsection (a) (including a definition of the summary required by paragraph (1)(C) of such section) not later than 12 months after the date of enactment of this Act [Nov. 28, 1990]. In promulgating the regulations, the Secretary shall minimize the administrative burdens on device user facilities consistent with the need to assure adequate information.”

Pub. L. 101–629, § 3(c), Nov. 28, 1990, 104 Stat. 4514, as amended by Pub. L. 102–300, § 2(a)(2), (3), June 16, 1992, 106 Stat. 238, provided that:

“(1)

(A)

Not later than 9 months after the date of the enactment of this Act [Nov. 28, 1990], the Secretary of Health and Human Services shall issue proposed regulations—

“(i)

to require distributors of devices to establish and maintain records and to make reports (including reports required by part 803 of title 21 of the Code of Federal Regulations) under section 519(a)(6) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(a)(6)], and

“(ii)

to implement section 519(e) of such Act.

The Secretary may exempt from regulations described in clause (i) classes of distributors of class I and class II devices from whom reports are not necessary for the protection of the public health.

“(B)

Regulations under subparagraph (A) shall—

“(i)

require appropriate methods for maintenance of records to ensure that patients who receive devices can be provided the notification required by such Act [this chapter],

“(ii)

require that manufacturers adopt effective methods of tracking devices,

“(iii)

take into account the position of distributors in the device distribution process, and

“(iv)

include such other requirements as the Secretary deems necessary for the adoption of an effective user tracking program under section 519(e) of such Act.

“(2)

Not later than 18 months after the date of the enactment of this Act, the Secretary shall issue final regulations to implement sections [sic] 519(a)(6) of the Federal Food, Drug, and Cosmetic Act. If the Secretary does not promulgate such final regulations upon the expiration of such 18 months, the Congress finds that there is good cause for the proposed regulations to be considered as the final regulations without response to comment because the implementation of sections [sic] 519(a)(6) of such Act is essential to protect the health of patients who use such devices. Consequently, in such event, the proposed regulations issued under paragraph (1) shall become final regulations as of the expiration of such 18 months. There shall be promptly published in the Federal Register notice of the new status of the proposed regulations.

“(3)

Not later than November 28, 1992, the Secretary shall issue final regulations to implement section 519(e) of the Federal Food, Drug, and Cosmetic Act. If the Secretary does not promulgate such final regulations by November 28, 1992, the Congress finds that there is good cause for the proposed regulations to be considered as the final regulations without response to comment because the implementation of section 519(e) of such Act is essential to protect the health of patients who use devices. In such event, the proposed regulations issued under paragraph (1) shall become the issued final regulations on November 29, 1992. There shall be promptly published in the Federal Register notice of the new status of the proposed regulations.”

[For effective date of amendment by Pub. L. 102–300, see section 2(b) of Pub. L. 102–300, set out above as an Effective Date of 1992 Amendment note.]

Information Concerning Reporting Requirements for Device User Facilities

Pub. L. 101–629, § 2(d), Nov. 28, 1990, 104 Stat. 4513, directed Secretary of Health and Human Services, during the 18-month period beginning on Nov. 28, 1990, to inform device user facilities (as defined in 21 U.S.C. 360i(b)(5)(A)) and manufacturers and distributors of devices respecting the requirements of 21 U.S.C. 360i(b), and, to the extent practicable, provide persons subject to such requirements assistance in the form of publications regarding such requirements.

Study of Reporting Requirements; Compliance by Device User Facilities; Actions by Manufacturers; Cost Effectiveness; Recommendations

Pub. L. 101–629, § 2(e), Nov. 28, 1990, 104 Stat. 4513, directed Comptroller General of the United States, not more than 36 months after Nov. 28, 1990, to conduct a study of compliance by device user facilities with the requirements of 21 U.S.C. 360i(b), actions taken by manufacturers of devices in response to reports made to them, cost effectiveness of such requirements and their implementation, and any recommendations for improvements to such requirements, with Comptroller General to complete the study and submit a report on the study not later than 45 months from Nov. 28, 1990, to appropriate committees of Congress.

Report to Congress on Reporting Requirements for Device User Facilities

Pub. L. 101–629, § 2(f), Nov. 28, 1990, 104 Stat. 4513, directed Secretary of Health and Human Services, not later than 36 months after Nov. 28, 1990, to prepare and submit to appropriate committees of Congress a report containing an evaluation of the requirements of 21 U.S.C. 360i(b), consisting of an evaluation of the safety benefits of the requirements, the burdens placed on the Food and Drug Administration and on device user facilities by the requirements, and the cost-effectiveness of the requirements and recommendations for legislative reform.