For termination of section by section 2007(b) of Pub. L. 117–180, see Effective and Termination Dates note below.

Section 201(b) of the Medical Device User Fee Amendments of 2022, referred to in subsec. (a)(1)(A), (B), (2), probably should be a reference to section 2001(b) of the Medical Device User Fee Amendments of 2022, title II of div. F of Pub. L. 117–180, which is set out as a note under section 379i of this title. The Medical Device User Fee Amendments of 2022 does not contain a section 201(b).

Section 360e–3 of this title, referred to in subsec. (a)(1)(A)(ii)(III), was in the original a reference to section 515C of act June 25, 1938, which was renumbered section 515B by Pub. L. 115–52, title IX, § 901(f)(2), Aug. 18, 2017, 131 Stat. 1077.

Section 2001(b) of the Medical Device User Fee Amendments of 2022, referred to in subsec. (a)(1)(A)(iv)(I), is section 2001(b) of title II of div. F of Pub. L. 117–180, which is set out as a note under section 379i of this title.

2022—Subsec. (a). Pub. L. 117–180, § 2004(a)(1), (2), substituted “fiscal year 2023” for “fiscal year 2018” and “Medical Device User Fee Amendments of 2022” for “Medical Device User Fee Amendments of 2017” wherever appearing.

Subsec. (a)(1)(A)(ii). Pub. L. 117–328, § 3626(b)(1)(A)(iii), inserted concluding provisions.

Subsec. (a)(1)(A)(ii)(IV), (V). Pub. L. 117–328, § 3626(b)(1)(A), added subcls. (IV) and (V).

Subsec. (a)(1)(A)(iv). Pub. L. 117–180, § 2004(a)(3)(B), substituted “fiscal year 2023” for “fiscal year 2020” in introductory provisions of cl. (iv) relating to rationale for MDUFA program changes.

Subsec. (a)(1)(A)(iv)(I). Pub. L. 117–328, § 3626(b)(1)(B)(i), amended subcl. (I) generally. Prior to amendment, subcl. (I) read as follows: “data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;”.

Subsec. (a)(1)(A)(iv)(II). Pub. L. 117–328, § 3626(b)(1)(B)(ii), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: “data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of devices, including identifying drivers of such changes; and”.

Subsec. (a)(1)(A)(iv)(IV). Pub. L. 117–328, § 3626(b)(1)(B)(iii), (iv), added subcl. (IV).

Subsec. (a)(1)(A)(v). Pub. L. 117–180, § 2004(a)(3)(A), redesignated cl. (iv) relating to analysis to be included in report as (v).

Subsec. (a)(4). Pub. L. 117–180, § 2004(a)(4), substituted “2023 through 2027” for “2018 through 2022”.

Subsec. (b)(1). Pub. L. 117–180, § 2004(b)(1), substituted “2027” for “2022” in introductory provisions.

Subsec. (b)(4). Pub. L. 117–328, § 3626(b)(2)(B), added par. (4). Former par. (4) redesignated (5).

Subsec. (b)(5). Pub. L. 117–328, § 3626(b)(2)(A), redesignated par. (4) as (5). Former par. (5) redesignated (6).

Pub. L. 117–180, § 2004(b)(2), substituted “2027” for “2022”.

Subsec. (b)(6), (7). Pub. L. 117–328, § 3626(b)(2)(A), redesignated pars. (5) and (6) as (6) and (7), respectively.

Subsec. (b)(7)(A). Pub. L. 117–328, § 3626(b)(2)(C)(i), substituted “The” for “Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the” and inserted “, not later than 30 days after each such negotiation meeting” before period at end.

Subsec. (b)(7)(B). Pub. L. 117–328, § 3626(b)(2)(C)(ii), inserted “, in sufficient detail,” after “shall summarize”.

2017—Subsec. (a)(1)(A). Pub. L. 115–52, § 903(b), designated existing provisions as cl. (i), inserted heading, and added cls. (ii), (iii), and (iv) related to rationale for MDUFA program changes.

Subsec. (a)(1)(A)(i). Pub. L. 115–52, § 204(a)(1)(A), substituted “2018” for “2013” and “the Medical Device User Fee Amendments of 2017” for “the Medical Device User Fee Amendments of 2012”.

Subsec. (a)(1)(A)(iv). Pub. L. 115–52, § 904(b)(1), added cl. (iv) relating to analysis to be included in report.

Subsec. (a)(1)(B). Pub. L. 115–52, § 204(a)(1)(B), substituted “the Medical Device User Fee Amendments of 2017” for “the Medical Device User Fee Amendments Act of 2012”.

Subsec. (a)(2), (3). Pub. L. 115–52, § 904(b)(2)(B), added pars. (2) and (3). Former pars. (2) and (3) redesignated (4) and (5), respectively.

Subsec. (a)(4). Pub. L. 115–52, § 904(b)(2)(A), redesignated par. (2) as (4).

Pub. L. 115–52, § 204(a)(2), which directed amendment of par. (2), effective Oct. 1, 2017, by substituting “2018 through 2022” for “2013 through 2017”, was executed by making the substitution in par. (4) to reflect the probable intent of Congress and the redesignation of par. (2) as (4), effective Aug. 18, 2017, by Pub. L. 115–52, § 904(b)(2)(A). See Amendment note above.

Subsec. (a)(5). Pub. L. 115–52, § 904(b)(2)(A), redesignated par. (3) as (5).

Subsec. (b)(1). Pub. L. 115–52, § 204(b)(1), substituted “2022” for “2017” in introductory provisions.

Subsec. (b)(5). Pub. L. 115–52, § 204(b)(2), substituted “2022” for “2017”.

2012—Subsec. (a)(1). Pub. L. 112–144, § 204(b)(1), added par. (1) and struck out former par. (1). Prior to amendment, text read as follows: “For fiscal years 2008 through 2012, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.”

Subsec. (a)(2). Pub. L. 112–144, § 204(b)(2), substituted “2013 through 2017” for “2008 through 2012”.

Subsec. (b)(1). Pub. L. 112–144, § 204(a)(1), substituted “2017” for “2012”.

Subsec. (b)(5). Pub. L. 112–144, § 204(a)(2), substituted “2017” for “2012”.

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

Amendment by section 204 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart 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.

Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as a note under section 379i of this title.

Pub. L. 117–180, div. F, title II, § 2007(b), Sept. 30, 2022, 136 Stat. 2154, provided that: “Section 738A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1) shall cease to be effective January 31, 2028.”

Pub. L. 115–52, title II, § 210(b), Aug. 18, 2017, 131 Stat. 1020, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Pub. L. 117–180, div. F, title II, § 2007(c), Sept. 30, 2022, 136 Stat. 2154.

[Pub. L. 117–180, div. F, title II, § 2007(c), Sept. 30, 2022, 136 Stat. 2154, provided that the repeal of section 210(b) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Section effective Oct. 1, 2007, except for certain premarket fees under this subpart, see section 216 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379i of this title.