H. R. 6833—36 
‘‘Fee Type 
Fiscal 
Year 
2023 
Fiscal 
Year 
2024 
Fiscal 
Year 
2025 
Fiscal 
Year 
2026 
Fiscal 
Year 
2027 
Premarket Application ....
$425,000 
$435,000 
$445,000 
$455,000 
$470,000 
Establishment Registra-
tion ................................
$6,250 
$6,875 
$7,100 
$7,575 
$8,465’’; 
and 
(3) by amending paragraph (3) to read as follows: 
‘‘(3) TOTAL
REVENUE
AMOUNTS
SPECIFIED.—For purposes 
of paragraph (1), the total revenue amounts specified in this 
paragraph are as follows: 
‘‘(A) $312,606,000 for fiscal year 2023. 
‘‘(B) $335,750,000 for fiscal year 2024. 
‘‘(C) $350,746,400 for fiscal year 2025. 
‘‘(D) $366,486,300 for fiscal year 2026. 
‘‘(E) $418,343,000 for fiscal year 2027.’’. 
(c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 738(c) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is 
amended— 
(1) in paragraph (1), by striking ‘‘2017’’ and inserting 
‘‘2022’’; 
(2) in paragraph (2)— 
(A) in subparagraph (A), by striking ‘‘2018’’ and 
inserting ‘‘2023’’; 
(B) in subparagraph (B)— 
(i) in the matter preceding clause (i), by striking 
‘‘fiscal year 2018’’ and inserting ‘‘fiscal year 2023’’; 
and 
(ii) in clause (ii), by striking ‘‘fiscal year 2016’’ 
and inserting ‘‘fiscal year 2022’’; 
(C) in subparagraph (C), by striking ‘‘Washington- 
Baltimore, DC–MD–VA–WV’’ and inserting ‘‘Washington- 
Arlington-Alexandria, DC–VA–MD–WV’’; and 
(D) in subparagraph (D), in the matter preceding clause 
(i), by striking ‘‘fiscal years 2018 through 2022’’ and 
inserting ‘‘fiscal years 2023 through 2027’’; 
(3) in paragraph (3), by striking ‘‘2018 through 2022’’ and 
inserting ‘‘2023 through 2027’’; 
(4) by redesignating paragraphs (4) and (5) as paragraphs 
(7) and (8), respectively; and 
(5) by inserting after paragraph (3) the following: 
‘‘(4) PERFORMANCE IMPROVEMENT ADJUSTMENT.— 
‘‘(A) IN
GENERAL.—For each of fiscal years 2025 
through 2027, after the adjustments under paragraphs (2) 
and (3), the base establishment registration fee amounts 
for such fiscal year shall be increased to reflect changes 
in the resource needs of the Secretary due to improved 
review performance goals for the process for the review 
of device applications identified in the letters described 
in section 2001(b) of the Medical Device User Fee Amend-
ments of 2022, as the Secretary determines necessary to 
achieve an increase in total fee collections for such fiscal 
year equal to the following amounts, as applicable: 
‘‘(i) For fiscal year 2025, the product of— 
‘‘(I) the amount determined under subpara-
graph (B)(i)(I); and
H. R. 6833—37 
‘‘(II) the applicable inflation adjustment under 
paragraph (2)(B) for such fiscal year. 
‘‘(ii) For fiscal year 2026, the product of— 
‘‘(I) the sum of the amounts determined under 
subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); 
and 
‘‘(II) the applicable inflation adjustment under 
paragraph (2)(B) for such fiscal year. 
‘‘(iii) For fiscal year 2027, the product of— 
‘‘(I) the sum of the amounts determined under 
subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); 
and 
‘‘(II) the applicable inflation adjustment under 
paragraph (2)(B) for such fiscal year. 
‘‘(B) AMOUNTS.— 
‘‘(i) PRESUBMISSION
AMOUNT.—For purposes of 
subparagraph (A), with respect to the Presubmission 
Written Feedback goal, the amounts determined under 
this subparagraph are as follows: 
‘‘(I) For fiscal year 2025, $15,396,600 if such 
goal for fiscal year 2023 is met. 
‘‘(II) For fiscal year 2026: 
‘‘(aa) $15,396,600 if such goal for fiscal 
year 2023 is met and such goal for fiscal year 
2024 is not met. 
‘‘(bb) $36,792,200 if such goal for fiscal 
year 2024 is met. 
‘‘(III) For fiscal year 2027: 
‘‘(aa) $15,396,600 if such goal for fiscal 
year 2023 is met and such goal for each of 
fiscal years 2024 and 2025 is not met. 
‘‘(bb) $36,792,200 if such goal for fiscal 
year 2024 is met and such goal for fiscal year 
2025 is not met. 
‘‘(cc) $40,572,600 if such goal for fiscal 
year 2025 is met. 
‘‘(ii) DE NOVO CLASSIFICATION REQUEST AMOUNT.— 
For purposes of subparagraph (A), with respect to the 
De Novo Decision goal, the amounts determined under 
this subparagraph are as follows: 
‘‘(I) For fiscal year 2026, $6,323,500 if such 
goal for fiscal year 2023 is met. 
‘‘(II) For fiscal year 2027: 
‘‘(aa) $6,323,500 if such goal for fiscal year 
2023 is met and such goal for fiscal year 2024 
is not met. 
‘‘(bb) $11,765,400 if such goal for fiscal 
year 2024 is met. 
‘‘(iii) PREMARKET
NOTIFICATION
AND
PREMARKET 
APPROVAL AMOUNT.—For purposes of subparagraph (A), 
with respect to the 510(k) decision goal, 510(k) Shared 
Outcome Total Time to Decision goal, PMA decision 
goal, and PMA Shared Outcome Total Time to Decision 
goal, the amounts determined under this subparagraph 
are as follows: 
‘‘(I) For fiscal year 2026, $1,020,000 if the 
4 goals for fiscal year 2023 are met.
H. R. 6833—38 
‘‘(II) For fiscal year 2027: 
‘‘(aa) $1,020,000 if the 4 goals for fiscal 
year 2023 are met and one or more of the 
4 goals for fiscal year 2024 are not met. 
‘‘(bb) $3,906,000 if the 4 goals for fiscal 
year 2024 are met. 
‘‘(C) PERFORMANCE CALCULATION.—For purposes of this 
paragraph, performance of the following goals shall be 
determined as specified in the letters described in section 
2001(b) of the Medical Device User Fee Amendments of 
2022 and based on data available, as follows: 
‘‘(i) The performance of the Presubmission Written 
Feedback goal shall be based on data available as 
of— 
‘‘(I) for fiscal year 2023, March 31, 2024; 
‘‘(II) for fiscal year 2024, March 31, 2025; and 
‘‘(III) for fiscal year 2025, March 31, 2026. 
‘‘(ii) The performance of the De Novo Decision goal, 
510(k) decision goal, 510(k) Shared Outcome Total 
Time to Decision goal, PMA decision goal, and PMA 
Shared Outcome Total Time to Decision goal shall 
be based on data available as of— 
‘‘(I) for fiscal year 2023, March 31, 2025; and 
‘‘(II) for fiscal year 2024, March 31, 2026. 
‘‘(D) GOALS DEFINED.—For purposes of this paragraph, 
the terms ‘Presubmission Written Feedback goal’, ‘De Novo 
Decision goal’, ‘510(k) decision goal’, ‘510(k) Shared Out-
come Total Time to Decision goal’, ‘PMA decision goal’, 
and ‘PMA Shared Outcome Total Time to Decision goal’ 
refer to the goals identified by the same names in the 
letters described in section 2001(b) of the Medical Device 
User Fee Amendments of 2022. 
‘‘(5) HIRING ADJUSTMENT.— 
‘‘(A) IN
GENERAL.—For each of fiscal years 2025 
through 2027, after the adjustments under paragraphs (2), 
(3), and (4), if applicable, if the number of hires to support 
the process for the review of device applications falls below 
the thresholds specified in subparagraph (B) for the 
applicable fiscal years, the base establishment registration 
fee amounts shall be decreased as the Secretary determines 
necessary to achieve a reduction in total fee collections 
equal to the hiring adjustment amount under subparagraph 
(C). 
‘‘(B) THRESHOLDS.—The thresholds specified in this 
subparagraph are as follows: 
‘‘(i) For fiscal year 2025, the threshold is 123 hires 
for fiscal year 2023. 
‘‘(ii) For fiscal year 2026, the threshold is 38 hires 
for fiscal year 2024. 
‘‘(iii) For fiscal year 2027, the threshold is— 
‘‘(I) 22 hires for fiscal year 2025 if the base 
establishment registration fees are not increased 
by the amount determined under paragraph 
(4)(A)(i); or 
‘‘(II) 75 hires for fiscal year 2025 if such fees 
are so increased.