21 USC 379 - Authority to assess and use device fees

View all text of Subpart 3 [§ 379i - § 379j-1]

§ 379j. Authority to assess and use device fees

(a) Types of fees

(1) In general

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

(A) In generalExcept 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

(ii) Further manufacturing use

(iii) State or Federal Government sponsors

(iv) Premarket notifications by third parties

(v) Pediatric conditions of use(I) In general(II) Subsequent proposal of adult conditions of use

(D) Refunds

(i) Application refused for filing

(ii) Application withdrawn before filing

(iii) Application withdrawn before first action

(iv) Modular applications withdrawn before first action

(v) Later withdrawn modular applications

(vi) Sole discretion to refund

(3) Annual establishment registration fee

(A) In general

(B) Exception

(i) In general

(ii) Small businesses fee waiver(I) Definition of small business(II) Waiver(III) Firms submitting tax returns to the United States Internal Revenue Service(IV) Firms not submitting tax returns to the United States Internal Revenue Service(V) Request for waiver

(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

(2) Base fee amounts specified

(3) Total revenue amounts specifiedFor 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.

(D) $366,486,300 for fiscal year 2026.

(E) $418,343,000 for fiscal year 2027.

(1) In general

(2) Inflation adjustments

(A) Adjustment to total revenue amounts

(B) Applicable inflation adjustmentThe 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.

(i) In generalSubject 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) LimitationsFor 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 amountsFor 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

(4) Performance improvement adjustment

(A) In generalFor 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 amountFor 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 amountFor 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 amountFor 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 calculationFor 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

(5) Hiring adjustment

(A) In general

(B) ThresholdsThe 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.

(C) Hiring adjustment amountThe hiring adjustment amount for fiscal year 2025 and each subsequent fiscal year is the product of—

(i) the number of hires by which the hiring goal specified in subparagraph (D) for the fiscal year before the prior fiscal year was not met;

(ii) $72,877; and

(iii) the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was not met.

(D) Hiring goalsThe hiring goals for each of fiscal years 2023 through 2025 are as follows:

(i) For fiscal year 2023, 144 hires.

(ii) For fiscal year 2024, 42 hires.

(iii) For fiscal year 2025:(I) 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i).(II) 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i).

(E) Number of hires

(6) Operating reserve adjustment

(A) In general

(B) Designated amountSubject to subparagraph (C), for each fiscal year, the designated amount in this subparagraph is equal to the sum of—

(i) 13 weeks of operating reserves of carryover user fees; and

(ii) 1 month of operating reserves maintained pursuant to paragraph (8).

(7) Limit

(8) Supplement

(A) In general

(B) Notice to Congress

(d) Small businesses; fee waiver and fee reduction regarding premarket approval fees

(1) In general

(2) Rules relating to premarket approval fees

(A) Definition

(B) Evidence of qualification

(i) In general

(ii) Firms submitting tax returns to the United States Internal Revenue Service

(iii) Firms not submitting tax returns to the United States Internal Revenue Service

(C) Reduced feesWhere the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—

(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, periodic reporting concerning a class III device, or a de novo classification request; and

(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.

(D) Request for fee waiver or reduction

(e) Small businesses; fee reduction regarding premarket notification submissions

(1) In general

(2) Rules relating to premarket notification submissions

(A) Definition

(B) Evidence of qualification

(i) In general

(ii) Firms submitting tax returns to the United States Internal Revenue Service

(iii) Firms not submitting tax returns to the United States Internal Revenue Service

(D) Request for reduction

(f) Effect of failure to pay fees

(1) No acceptance of submissions

(2) No registration

(g) Conditions

(1) Performance goals; termination of programWith respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if—

(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is more than 1 percent less than $398,566,000 multiplied by the adjustment factor applicable to such fiscal year; or

(B) fees were not assessed under subsection (a) for the previous fiscal year.

(2) Authority

(3) Limitation

(h) Crediting and availability of fees

(1) In general

(2)

(A) In generalThe fees authorized by this section—

(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and

(ii) shall be available—(I) for fiscal year 2023, to defray increases in the costs of the resources allocated for the process for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor; and(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connection with the process for the review of device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.

(B) Compliance

(i) In generalThe Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable—(I) are not more than 3 percent below the level specified in subparagraph (A)(ii); or(II)(aa) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for a subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and(bb) such costs are not more than 5 percent below the level specified in such subparagraph.

(ii) More than 5 percent

(3) Authorization of appropriations

(A) In general

(B) Revenue amountFor purposes of this paragraph, the revenue amount for each fiscal year is the sum of—

(i) the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under paragraphs (2) and (3) of subsection (c); and

(ii) the performance improvement adjustment amount for the fiscal year under subsection (c)(4), if applicable.

(i) the hiring adjustment amount for the fiscal year under subsection (c)(5), if applicable; and

(ii) the operating reserve adjustment amount for the fiscal year under subsection (c)(6), if applicable.

(i) Collection of unpaid fees

(j) Written requests for refunds

(k) Construction

(June 25, 1938, ch. 675, § 738, as added Pub. L. 107–250, title I, § 102(a), Oct. 26, 2002, 116 Stat. 1591; amended Pub. L. 108–214, § 2(a)(2), (d)(2)(A), (B), (3)(A), Apr. 1, 2004, 118 Stat. 572, 576, 577; Pub. L. 109–43, § 2(a), Aug. 1, 2005, 119 Stat. 439; Pub. L. 110–85, title II, § 212, Sept. 27, 2007, 121 Stat. 844; Pub. L. 112–144, title II, § 203(a)–(f), July 9, 2012, 126 Stat. 1002; Pub. L. 112–193, § 2(b)(1), Oct. 5, 2012, 126 Stat. 1443; Pub. L. 115–52, title II, § 203(a)–(f)(1), (2)(B)–(i), title IX, § 905(b)(2), Aug. 18, 2017, 131 Stat. 1013–1016, 1090; Pub. L. 117–180, div. F, title II, § 2003, Sept. 30, 2022, 136 Stat. 2148; Pub. L. 117–328, div. FF, title III, §§ 3309, 3625(d), (e)(1), Dec. 29, 2022, 136 Stat. 5836, 5882.)