§ 379j. Authority to assess and use device fees

§ 379j. Authority to assess and use device fees

(a) Types of fees

(1) In general Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section.

(2) Premarket application, premarket report, supplement, and submission fee, and annual fee for periodic reporting concerning a class III device

(A) In general Except as provided in subparagraph (B) and subsections (d) and (e), each person who submits any of the following, on or after October 1, 2022, shall be subject to a fee established under subsection (c) for the fiscal year involved in accordance with the following:

(i) A premarket application.

(ii) For a premarket report, a fee equal to the fee that applies under clause (i).

(iii) For a panel track supplement, a fee equal to 80 percent of the fee that applies under clause (i).

(iv) For a 180-day supplement, a fee equal to 15 percent of the fee that applies under clause (i).

(v) For a real-time supplement, a fee equal to 7 percent of the fee that applies under clause (i).

(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).

(vii) For an efficacy supplement, a fee equal to the fee that applies under clause (i).

(viii) For a premarket notification submission, a fee equal to 4.5 percent of the fee that applies under clause (i).

(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i).

(x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).

(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).

(B) Exceptions

(i) Humanitarian device exemption An application under section 360j(m) of this title is not subject to any fee under subparagraph (A).

(ii) Further manufacturing use No fee shall be required under subparagraph (A) for the submission of a premarket application under section 262 of title 42 for a product licensed for further manufacturing use only.

(iii) State or Federal Government sponsors No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, premarket notification submission, or de novo classification request submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.

(iv) Premarket notifications by third parties No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to section 360m of this title.

(v) Pediatric conditions of use

(I) In general No fee shall be required under subparagraph (A) for a premarket application, premarket report, premarket notification submission, or de novo classification request if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.

(II) Subsequent proposal of adult conditions of use In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.

(C) Payment The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request. Applicants submitting portions of applications pursuant to section 360e(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.

(D) Refunds

(i) Application refused for filing The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is refused for filing.

(ii) Application withdrawn before filing The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is withdrawn prior to the filing decision of the Secretary.

(iii) Application withdrawn before first action After receipt of a request for a refund of the fee paid under subparagraph (A) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement.

(iv) Modular applications withdrawn before first action The Secretary shall refund 75 percent of the application fee paid for an application submitted under section 360e(c)(4) of this title that is withdrawn before a second portion is submitted and before a first action on the first portion.

(v) Later withdrawn modular applications If an application submitted under section 360e(c)(4) of this title is withdrawn after a second or subsequent portion is submitted but before any first action, the Secretary may return a portion of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of the portions submitted.

(vi) Sole discretion to refund The Secretary shall have sole discretion to refund a fee or portion of the fee under clause (iii) or (v). A determination by the Secretary concerning a refund under clause (iii) or (v) shall not be reviewable.

(3) Annual establishment registration fee

(A) In general Except as provided in subparagraph (B), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under section 360 of this title beginning with its registration for fiscal year 2008.

(B) Exception

(i) In general No fee shall be required under subparagraph (A) for an establishment operated by a State or Federal governmental entity or an Indian tribe (as defined in the Indian Self Determination and Educational Assistance Act 11 See References in Text note below. [25 U.S.C. 5301 et seq.]), unless a device manufactured by the establishment is to be distributed commercially.

(ii) Small businesses fee waiver

(I) Definition of small business For purposes of this clause, the term “small business” means an entity that reported $1,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.

(II) Waiver The Secretary may grant a waiver of the fee required under subparagraph (A) for the annual registration (excluding the initial registration) of an establishment for a year, beginning on October 1, 2024, if the Secretary finds that the establishment is a small business and paying the fee for such year represents a financial hardship to the establishment as determined by the Secretary.

(III) Firms submitting tax returns to the United States Internal Revenue Service The establishment shall support its claim that it meets the definition under subclause (I) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subclause (I). The establishment, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the establishment shall certify that the establishment has no affiliates.

(IV) Firms not submitting tax returns to the United States Internal Revenue Service In the case of an establishment that has not previously submitted a Federal income tax return, the establishment and each of its affiliates shall demonstrate that it meets the definition under subclause (I) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the establishment or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the establishment or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the establishment’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The establishment shall also submit a statement signed by the head of the establishment’s firm or by its chief financial officer that the establishment has submitted certifications for all of its affiliates, or that the establishment has no affiliates.

(V) Request for waiver An establishment seeking a fee waiver for a year under this clause shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subparagraph (C). The decision of the Secretary regarding whether an entity may receive the waiver for such year is not reviewable.

(C) Payment The fee required under subparagraph (A) shall be due once each fiscal year, upon the later of—

(i) the initial or annual registration (as applicable) of the establishment under section 360 of this title; or

(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(b) Fee Amounts

(1) In general Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2023 through 2027, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3).

(2) Base fee amounts specified For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows: Fee TypeFiscal Year 2023Fiscal Year 2024Fiscal Year 2025Fiscal Year 2026Fiscal 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

(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

(1) In general The Secretary shall, 60 days before the start of each fiscal year after September 30, 2022, establish fees under subsection (a), based on amounts specified under subsection (b) and the adjustments provided under this subsection, and publish such fees, and the rationale for any adjustments to such fees, in the Federal Register.

(2) Inflation adjustments

(A) Adjustment to total revenue amounts For fiscal year 2023 and each subsequent fiscal year, the Secretary shall adjust the total revenue amount specified in subsection (b)(3) for such fiscal year by multiplying such amount by the applicable inflation adjustment under subparagraph (B) for such year.

(B) Applicable inflation adjustment The applicable inflation adjustment for fiscal year 2023 and each subsequent fiscal year is the product of—

(i) the base inflation adjustment under subparagraph (C) for such fiscal year; and

(ii) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2022.

(C) Base inflation adjustment

(i) In general Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus—

(I) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by 0.60; and

(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by 0.40.

(ii) Limitations For purposes of subparagraph (B), if the base inflation adjustment for a fiscal year under clause (i)—

(I) is less than 1, such adjustment shall be considered to be equal to 1; or

(II) is greater than 1.04, such adjustment shall be considered to be equal to 1.04.

(D) Adjustment to base fee amounts For each of fiscal years 2023 through 2027, the Secretary shall—

(i) adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph (B) for such year; and

(ii) if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).

(3) Volume-based adjustments to establishment registration base fees For each of fiscal years 2023 through 2027, after the base fee amounts specified in subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment registration fee amounts specified in such subsection shall be increased, as the Secretary estimates is necessary in order for total fee collections for such fiscal year to generate the total revenue amounts, as adjusted under paragraph (2).

(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 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:

(i) For fiscal year 2025, the product of—

(I) the amount determined under subparagraph (B)(i)(I); and

(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.

(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 Outcome 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