Sec. 203. Authority to assess and use device fees
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Section 738(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(a) ) is amended— in paragraph (1), by striking 2018 and inserting 2023 ; and in paragraph (2)— in subparagraph (A)— in the matter preceding clause (i), by striking 2017 and inserting 2022 ; in clause (iii), by striking 75 percent and inserting 80 percent ; and in clause (viii), by striking 3.4 percent and inserting 4.5 percent ; in subparagraph (B)(iii), by striking or premarket notification submission and inserting premarket notification submission, or de novo classification request ; and in subparagraph (C), by striking or periodic reporting concerning a class III device and inserting periodic reporting concerning a class III device, or de novo classification request .
Section 738(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(b) ) is amended— in paragraph (1), by striking 2018 through 2022 and inserting 2023 through 2027 ; by amending the table in paragraph
(2)to read as follows: 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 Registration $6,250 $6,875 $7,100 $7,575 $8,465 ; and in paragraph (3), by amending subparagraphs
(A)through
(E)to read as follows: $312,606,000 for fiscal year 2023. $335,750,000 for fiscal year 2024. $350,746,400 for fiscal year 2025. $366,486,300 for fiscal year 2026. $418,343,000 for fiscal year 2027. . Section 738(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(c) ) is amended— in paragraph (1), by striking 2017 and inserting 2022 ; in paragraph (2)— by striking 2018 each place it appears and inserting 2023 ; in subparagraph (B)(ii), by striking 2016 and inserting 2022 ; in subparagraph (C)(i)(II), by striking Washington-Baltimore, DC–MD–VA–WV and inserting Washington–Arlington–Alexandria, DC–VA–MD–WV ; and in subparagraph (D), by striking 2022 and inserting 2027 ; in paragraph (3), by striking 2018 through 2022 and inserting 2023 through 2027 ; by redesignating paragraphs
(4)and
(5)as paragraphs
(7)and (8), respectively; and by inserting after paragraph
(3)the following: For each of fiscal years 2025 through 2027, after the adjustment under paragraph (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 201(b) of the Medical Device User Fee Amendments 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: For fiscal year 2025, the product of— the amount determined under subparagraph (B)(i)(I); and the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. For fiscal year 2026, the product of— the sum of the amounts determined under subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. For fiscal year 2027, the product of— the sum of the amounts determined under subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. For purposes of subparagraph (A), with respect to the presubmission written feedback goal, the amounts determined under this subparagraph are as follows: For fiscal year 2025, $15,396,600 if the goal for fiscal year 2023 is met. For fiscal year 2026— $15,396,600 if the goal for fiscal year 2023 is met and the goal for fiscal year 2024 is missed; or $36,792,200 if the goal for fiscal year 2024 is met. For fiscal year 2027— $15,396,600 if the goal for fiscal year 2023 is met and the goal for each of fiscal years 2024 and 2025 is missed; $36,792,200 if the goal for fiscal year 2024 is met and the goal for fiscal year 2025 is missed; or $40,572,600 if the goal for fiscal year 2025 is met. For purposes of subparagraph (A), with respect to the de novo decision goal, the amounts determined under this subparagraph are as follows: For fiscal year 2026, $6,323,500 if the goal for fiscal year 2023 is met. For fiscal year 2027— $6,323,500 if the goal for fiscal year 2023 is met and the goal for fiscal year 2024 is missed; or $11,765,400 if the goal for fiscal year 2024 is met. 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: For fiscal year 2026, $1,020,000 if the 4 goals for fiscal year 2023 are met. For fiscal year 2027— $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 is missed; or $3,906,000 if the 4 goals for fiscal year 2024 are met. For purposes of this paragraph, performance of the following goals shall be determined as specified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022 and based on data available as of the applicable dates as follows: The performance of the presubmission written feedback goal— for fiscal year 2023, shall be based on data available as of March 31, 2024; for fiscal year 2024, shall be based on data available as of March 31, 2025; and for fiscal year 2025, shall be based on data available as of March 31, 2026. 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— for fiscal year 2023, shall be based on data available as of March 31, 2025; and for fiscal year 2024, shall be based on data available as of March 31, 2026. For purposes of this paragraph, the terms presubmission written feedback goal , 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 have the meanings given such terms in the goals identified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022. For each of fiscal years 2025 through 2027, after the adjustments under paragraphs
(3)and (4), if applicable, 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 (B), if the number of hires to support the process for the review of device applications falls below the following thresholds for the applicable fiscal years: For fiscal year 2025, 85 percent of the hiring goal specified in subparagraph
(C)for fiscal year 2023. For fiscal year 2026, 90 percent of the hiring goal specified in subparagraph
(C)for fiscal year 2024. For fiscal year 2027, 90 percent of the hiring goal specified in subparagraph
(C)for fiscal year 2025. The hiring adjustment amount for fiscal year 2025 and each subsequent fiscal year is the product of— the number of hires by which the hiring goal specified in subparagraph
(C)for the fiscal year before the prior fiscal year was missed; $72,877; and the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was missed. For purposes of subparagraph (B), the hiring goals for each of fiscal years 2023 through 2025 are as follows: For fiscal year 2023, 144 hires. For fiscal year 2024, 42 hires. For fiscal year 2025— 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i); or 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i). For purposes of this paragraph, the number of hires for a fiscal year shall be determined by the Secretary, as set forth in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022. For each of fiscal years 2023 through 2027, after the adjustments under paragraphs (3), (4), and (5), if applicable, if the Secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph (B), the Secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves. Subject to subparagraph (C), for each fiscal year, the designated amount in this subparagraph is equal to the sum of— 13 weeks of operating reserves of carryover user fees; and the 1 month of operating reserves described in paragraph (8). For the period of fiscal years 2023 through 2026, a total amount equal to $118,000,000 shall not be considered part of the designated amount under subparagraph
(B)and shall not be subject to the decrease under subparagraph (A). . Section 738(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(g) ) is amended— in paragraph (1)(A), by striking $320,825,000 and inserting $398,566,000 ; and in paragraph (2), by inserting de novo classification requests, after class III device, . Section 738(h)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(h)(3) ) is amended to read as follows: For each of the fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined in subparagraph (B), less the amount of reductions determined in subparagraph (C). For purposes of this paragraph, the revenue amount for each fiscal year is the sum of— the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under subsection (c)(2); and the performance improvement adjustment amount for the fiscal year under subsection (c)(4)(A), if applicable. For purposes of this paragraph, the amount of reductions for each fiscal year is the sum of— the hiring adjustment amount for the fiscal year under subsection (c)(5), if applicable; and the operating reserve adjustment amount for the fiscal year under subsection (c)(6), if applicable. .
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Sec. 203
Authority to assess and use device fees
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