H. R. 6833—34 
of each fiscal year for which fees are collected under this 
part’’; 
(4) in subsection (a)(4), by striking ‘‘Beginning with fiscal 
year 2020, the’’ and inserting ‘‘The’’; 
(5) in subsection (b), by striking ‘‘Beginning with fiscal 
year 2018, not’’ and inserting ‘‘Not’’; 
(6) in subsection (c), by striking ‘‘Beginning with fiscal 
year 2018, for’’ and inserting ‘‘For’’; and 
(7) in subsection (f)— 
(A) in paragraph (1), in the matter preceding subpara-
graph (A), by striking ‘‘fiscal year 2022’’ and inserting 
‘‘fiscal year 2027’’; and 
(B) in paragraph (5), by striking ‘‘January 15, 2022’’ 
and inserting ‘‘January 15, 2027’’. 
SEC. 1005. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 735 and 736 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to 
be effective October 1, 2027. 
(b) REPORTING REQUIREMENTS.—Section 736B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to 
be effective January 31, 2028. 
(c) PREVIOUS SUNSET PROVISION.—Effective October 1, 2022, 
subsections (a) and (b) of section 104 of the FDA Reauthorization 
Act of 2017 (Public Law 115–52) are repealed. 
SEC. 1006. EFFECTIVE DATE. 
The amendments made by this title shall take effect on October 
1, 2022, or the date of the enactment of this Act, whichever is 
later, except that fees under part 2 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g 
et seq.) shall be assessed for all human drug applications received 
on or after October 1, 2022, regardless of the date of the enactment 
of this Act. 
SEC. 1007. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, part 2 
of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379g et seq.), as in effect on the day 
before the date of the enactment of this title, shall continue to 
be in effect with respect to human drug applications and supple-
ments (as defined in such part as of such day) that were accepted 
by the Food and Drug Administration for filing on or after October 
1, 2017, but before October 1, 2022, with respect to assessing 
and collecting any fee required by such part for a fiscal year 
prior to fiscal year 2023. 
TITLE II—FEES RELATING TO DEVICES 
SEC. 2001. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Medical 
Device User Fee Amendments of 2022’’. 
(b) FINDING.—Congress finds that the fees authorized under 
the amendments made by this title will be dedicated toward expe-
diting the process for the review of device applications and for 
assuring the safety and effectiveness of devices, as set forth in 
the goals identified for purposes of part 3 of subchapter C of
H. R. 6833—35 
chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379i et seq.), in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of Rep-
resentatives, as set forth in the Congressional Record. 
SEC. 2002. DEFINITIONS. 
Section 737 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379i) is amended— 
(1) in paragraph (9)— 
(A) in the matter preceding subparagraph (A), by 
striking ‘‘and premarket notification submissions’’ and 
inserting ‘‘premarket notification submissions, and de novo 
classification requests’’; 
(B) in subparagraph (D), by striking ‘‘and submissions’’ 
and inserting ‘‘submissions, and de novo classification 
requests’’; 
(C) in subparagraph (F), by striking ‘‘and premarket 
notification submissions’’ and inserting ‘‘premarket notifica-
tion submissions, and de novo classification requests’’; 
(D) in each of subparagraphs (G) and (H), by striking 
‘‘or submissions’’ and inserting ‘‘submissions, or requests’’; 
and 
(E) in subparagraph (K), by striking ‘‘or premarket 
notification submissions’’ and inserting ‘‘premarket notifica-
tion submissions, or de novo classification requests’’; and 
(2) in paragraph (11), by striking ‘‘2016’’ and inserting 
‘‘2021’’. 
SEC. 2003. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
(a) TYPES OF FEES.—Section 738(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j(a)) is amended— 
(1) in paragraph (1), by striking ‘‘fiscal year 2018’’ and 
inserting ‘‘fiscal year 2023’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), by striking 
‘‘October 1, 2017’’ and inserting ‘‘October 1, 2022’’; 
(ii) in clause (iii), by striking ‘‘75 percent’’ and 
inserting ‘‘80 percent’’; and 
(iii) in clause (viii), by striking ‘‘3.4 percent’’ and 
inserting ‘‘4.5 percent’’; 
(B) in subparagraph (B)(iii), by striking ‘‘or premarket 
notification submission’’ and inserting ‘‘premarket notifica-
tion submission, or de novo classification request’’; and 
(C) in subparagraph (C), by striking ‘‘or periodic 
reporting concerning a class III device’’ and inserting ‘‘peri-
odic reporting concerning a class III device, or de novo 
classification request’’. 
(b) FEE AMOUNTS.—Section 738(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j(b)) is amended— 
(1) in paragraph (1), by striking ‘‘2018 through 2022’’ and 
inserting ‘‘2023 through 2027’’; 
(2) by amending paragraph (2) to read as follows: 
‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For purposes of para-
graph (1), the base fee amounts specified in this paragraph 
are as follows: