21 U.S.C. § 379j — Authority to assess and use device fees
submitted 88 years ago by Pub. L. 107-250 to r/title-21-FOOD-AND-DRUGS · 6,199 words · no verdicts yet
This law lets the FDA charge fees on medical device applications and registrations, starting in 2023. It sets base fee amounts through 2027 and adjusts them yearly for inflation, hiring, and performance. Small businesses may get waivers or reduced rates, and unpaid fees block review or registration.
(a) Types of fees.
(1) Starting in fiscal year 2023, the FDA ("the Secretary*") must charge and collect fees under this section every year.
(2) Premarket application*, report, supplement, and submission fees, plus an annual class III device fee.
(A) Starting October 1, 2022, anyone who submits certain device paperwork must pay a fee, unless an exception applies. There's a base fee for a premarket application. Other submissions pay a percentage of that base fee: a premarket report* pays the same amount as an application; a panel track supplement pays 80%; a 180-day supplement* pays 15%; a real-time supplement* pays 7%; a 30-day notice* pays 1.6%; an efficacy supplement* pays the full amount; a premarket notification (like a 510(k)) pays 4.5%; a request for classification information* pays 1.35%; an annual class III device report pays 3.5%; and a "de novo" classification request pays 30%.
(B) Five exceptions. No fee applies to: (i) a humanitarian device exemption application; (ii) a premarket application for a product licensed only for further manufacturing use; (iii) a submission by a State or Federal government entity, unless the device will be sold commercially; (iv) a premarket notification reviewed by an accredited third party; or (v) an application, report, notification, or de novo request whose only proposed use is for children, and a supplement whose only purpose is to add a pediatric use. But if someone later files a supplement proposing use in adults, that supplement must pay the full application fee.
(C) Payment. The fee is due when the submission is made. If an application is submitted in separate portions (a "modular" application), the fee is due with the first portion.
(D) Refunds. (i) If the FDA refuses to file the application, report, or supplement, it must refund 75% of the fee. (ii) If the applicant withdraws before the FDA decides whether to file it, the FDA must refund 75%. (iii) If the applicant withdraws after filing but before the FDA's first review action, the FDA may refund part of the fee, based on how much work it already did — this decision is entirely up to the FDA and can't be appealed. (iv) For a modular application withdrawn before the second portion is submitted and before a first action, the FDA must refund 75%. (v) For a modular application withdrawn after a second or later portion is submitted but before a first action, the FDA may refund part of the fee based on work already done — also not appealable. (vi) The FDA has full, unreviewable discretion over refunds under (iii) and (v).
(3) Annual establishment registration fee.
(A) Starting with fiscal year 2008 registration, each device-manufacturing establishment that registers under section 360 must pay a fee for each initial or annual registration.
(B) Exceptions: (i) A State, Federal, or tribal government-run establishment doesn't pay, unless it sells devices commercially. (ii) Small businesses — defined here as reporting $1,000,000 or less in gross receipts or sales, counting all affiliates — may get their annual (not initial) registration fee waived, for years starting October 1, 2024, if the FDA finds paying it would be a financial hardship. To prove they qualify, businesses (and their affiliates) must submit copies of their most recent federal tax returns and certify they're accurate; if a firm has never filed U.S. tax returns, it and its affiliates must instead submit a signed certification plus a certification from their home country's tax authority, sealed and stated in U.S. dollars. Waiver requests are due at least 60 days before the fee is owed, and the FDA's waiver decision can't be appealed.
(C) Payment. The registration fee is due once a year, whichever is later: when the establishment does its initial or annual registration, or the first business day after Congress enacts the appropriations law funding fee collection for that year.
(b) Fee amounts.
(1) For fiscal years 2023–2027, fees are based on the base amounts below, adjusted to raise the total revenue targets below.
(2) Base fee table — Premarket Application / Establishment Registration: FY2023 $425,000 / $6,250; FY2024 $435,000 / $6,875; FY2025 $445,000 / $7,100; FY2026 $455,000 / $7,575; FY2027 $470,000 / $8,465.
(3) Total revenue targets: FY2023 $312,606,000; FY2024 $335,750,000; FY2025 $350,746,400; FY2026 $366,486,300; FY2027 $418,343,000.
(c) Annual fee setting; adjustments.
(1) Sixty days before each fiscal year after September 30, 2022, the FDA must set the actual fees, based on (b) and the adjustments below, and publish them — with reasons for any adjustment — in the Federal Register.
(2) Inflation adjustments. Each year's total revenue target is multiplied by an inflation factor. That factor is built from: the average yearly change in FDA staff pay-and-benefits cost (weighted 60%), and the average yearly change in the Washington, DC-area Consumer Price Index (weighted 40%), each measured using the first 3 of the previous 4 years of data — then compounded with every prior year's factor going back to FY2022. The combined factor can never go below 1 (no negative adjustment) or above 1.04 (capped at a 4% increase). Base fee amounts are then multiplied by this same factor; if that alone won't hit the revenue target, the FDA may raise the base fees further, proportionally across the board.
(3) Volume-based adjustment. After the inflation adjustment, the FDA may raise the base establishment registration fee further, as needed, so total collections reach the inflation-adjusted revenue target.
(4) Performance improvement adjustment. For FY2025–2027, if the FDA hits certain review-speed goals (for presubmission feedback, de novo decisions, and 510(k)/PMA decisions) named in specified earlier years, it may raise the registration fee further to fund continued improved performance, by set dollar amounts — for example, $15,396,600 for FY2025 if the FY2023 presubmission goal was met, rising to as much as $40,572,600 for FY2027 as more years' goals are met — each amount multiplied by that year's inflation factor. The section spells out exactly which prior year's goal triggers which dollar amount for FY2025, FY2026, and FY2027, separately for the presubmission-feedback goal, the de novo goal, and the combined 510(k)/PMA goals, and defines the specific dates used to measure whether each goal was met.
(5) Hiring adjustment. For FY2025–2027, if the FDA falls short of hiring targets — 144 hires for FY2023, 42 for FY2024, and either 24 or 83 for FY2025 depending on whether (4) applied — by the thresholds set in the section, the registration fee must be lowered. The reduction equals the number of missing hires times $72,877, adjusted for that year's inflation factor.
(6) Operating reserve adjustment. If the FDA is holding more in leftover ("carryover") device-fee reserves than 13 weeks' worth plus one month of the reserve required under (8), it must lower the registration fee to bring reserves back down — except that $118,000,000 total across FY2023–2026 doesn't count toward this excess and can't be reduced this way.
(7) Limit. In any year, total fees collected can't exceed what the FDA actually spends that year reviewing device applications.
(8) Supplement. The FDA may use unspent fees from past years to cover a shortfall, as long as it keeps at least one month's reserve going into the next fiscal year, and must notify the relevant Senate and House committees at least 14 days before doing so.
(d) Small business waiver/reduction for premarket approval fees.
(1) The FDA must waive the fee for a small business's very first premarket application, and separately for its first premarket report. Here, "small business" means $30,000,000 or less in gross receipts or sales, including affiliates. For later applications, reports, and supplements, a small business (under the larger definition in (2)) can pay a reduced rate.
(2) Rules: (A) For this reduced-rate program, "small business" means $100,000,000 or less in gross receipts or sales, including affiliates. (B) Applicants must prove they qualify with tax returns from themselves and their affiliates — or, for applicants that have never filed U.S. tax returns, a signed certification plus a certification from their home country's tax authority — or else they pay the full fee. (C) Qualifying small businesses pay 25% of the normal fee for a premarket application, report, supplement, class III periodic report, or de novo request, and 50% of the normal fee for a 30-day notice or classification-information request. (D) Businesses must request the waiver or reduction at least 60 days before the fee is due; the FDA's decision can't be appealed.
(e) Small business fee reduction for premarket notifications.
(1) Starting FY2008, a qualifying small business can pay a reduced rate on the premarket notification (510(k)) fee.
(2) Rules: (A) "Small business" means $100,000,000 or less in gross receipts or sales, including affiliates — proven the same way as in (d). (C) Qualifying businesses pay 25% of the normal fee. (D) The reduction request is due at least 60 days before the fee is owed; the decision isn't appealable.
(f) Effect of failure to pay fees.
(1) The FDA treats an application, report, supplement, notification, notice, or request as incomplete — and won't accept it — until all fees owed by the submitter are paid.
(2) Same for establishment registration: it's treated as incomplete, and the establishment as unregistered, until the registration fee is paid.
(g) Conditions.
(1) If Congress funds the FDA's device program for a year at more than 1% below a set floor of $398,566,000 (adjusted for inflation) — not counting fee money — or if fees weren't collected the year before, then the FDA can't collect fees that year and isn't held to its performance goals for that year.
(2) If the FDA skips fees for part of a year under (1) but conditions improve later that same year, it can resume collecting fees at the normal rate, regardless of the usual due dates.
(3) Starting October 1, 2023, a related spending authority (section 379i(10)(C)) covers only equipment leasing and necessary scientific equipment.
(h) Crediting and availability of fees.
(1) Fees can only be spent up to the amount Congress allows in appropriations laws, but stay available until spent. The FDA may transfer money between its salaries-and-expenses accounts as needed for device review, without the usual fiscal-year expiration limits.
(2) The FDA can only spend fee money for its intended purpose if Congress's non-fee funding for device review meets a baseline tied to fiscal year 2009 spending, adjusted for inflation — one rule for FY2023, a similar one for FY2024 onward.
(3) Compliance: the FDA is treated as compliant if non-fee funding is within 3% of that baseline. If it falls 3–5% short, fees for a later year are cut by the excess shortfall, as long as funding stays within 5% overall. If non-fee funding falls more than 5% short, the FDA can't collect fees that year at all. The FDA may also accept early fee payments if a prior year's appropriations law allows it.
(3) [Authorization of appropriations] For FY2023–2027, Congress is authorized to fund device fees at an amount equal to the target revenue (as adjusted for inflation, volume, and performance improvements), minus any hiring or operating-reserve reductions.
(i) Collection of unpaid fees. If a fee isn't paid within 30 days of its due date, it's treated as a debt owed to the U.S. government, handled under the federal debt-collection law.
(j) Written requests for refunds. To get a refund under (a)(2)(D), someone must submit a written request no later than 180 days after the fee was due.
(k) Construction. This section doesn't require the FDA to cut staff who aren't involved in device review just to offset the staff who are.
Beginning in fiscal year 2023, the Secretary* shall assess and collect fees in accordance with this section.
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:
A premarket application.
For a premarket report, a fee equal to the fee that applies under clause (i).
For a panel track supplement, a fee equal to 80 percent of the fee that applies under clause (i).
For a 180-day supplement*, a fee equal to 15 percent of the fee that applies under clause (i).
For a real-time supplement*, a fee equal to 7 percent of the fee that applies under clause (i).
For a 30-day notice*, a fee equal to 1.6 percent of the fee that applies under clause (i).
For an efficacy supplement*, a fee equal to the fee that applies under clause (i).
For a premarket notification submission*, a fee equal to 4.5 percent of the fee that applies under clause (i).
For a request for classification information*, a fee equal to 1.35 percent of the fee that applies under clause (i).
For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).
For a de novo classification request*, a fee equal to 30 percent of the fee that applies under clause (i).
An application under section 360j(m) of this title is not subject to any fee under subparagraph (A).
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.
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.
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.
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.
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.
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.
The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is refused for 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.
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.
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.
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.
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.
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.
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 1 [25 U.S.C. 5301 et seq.]), unless a device manufactured by the establishment is to be distributed commercially.
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.
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.
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.
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.
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.
The fee required under subparagraph (A) shall be due once each fiscal year, upon the later of—
the initial or annual registration (as applicable) of the establishment under section 360 of this title; or
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.
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).
For purposes of paragraph (1), the base fee amounts specified in this paragraph are 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 |
For purposes of paragraph (1), the total revenue amounts specified in this paragraph are 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.
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.
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.
The applicable inflation adjustment for fiscal year 2023 and each subsequent fiscal year is the product of—
the base inflation adjustment under subparagraph (C) for such fiscal year; and
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.
Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus—
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
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.
For purposes of subparagraph (B), if the base inflation adjustment for a fiscal year under clause (i)—
is less than 1, such adjustment shall be considered to be equal to 1; or
is greater than 1.04, such adjustment shall be considered to be equal to 1.04.
For each of fiscal years 2023 through 2027, the Secretary shall—
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
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).
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).
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:
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 such goal for fiscal year 2023 is met.
For fiscal year 2026:
$15,396,600 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.
$36,792,200 if such goal for fiscal year 2024 is met.
For fiscal year 2027:
$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.
$36,792,200 if such goal for fiscal year 2024 is met and such goal for fiscal year 2025 is not met.
$40,572,600 if such 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 such goal for fiscal year 2023 is met.
For fiscal year 2027:
$6,323,500 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.
$11,765,400 if such 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 are not met.
$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 2001(b) of the Medical Device User Fee Amendments of 2022 and based on data available, as follows:
The performance of the Presubmission Written Feedback goal shall be based on data available as of—
for fiscal year 2023, March 31, 2024;
for fiscal year 2024, March 31, 2025; and
for fiscal year 2025, 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 shall be based on data available as of—
for fiscal year 2023, March 31, 2025; and
for fiscal year 2024, 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” 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.
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).
The thresholds specified in this subparagraph are as follows:
For fiscal year 2025, the threshold is 123 hires for fiscal year 2023.
For fiscal year 2026, the threshold is 38 hires for fiscal year 2024.
For fiscal year 2027, the threshold is—
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
75 hires for fiscal year 2025 if such fees are so increased.
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 (D) for the fiscal year before the prior fiscal year was not met;
$72,877; and
the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was not met.
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).
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 2001(b) of the Medical Device User Fee Amendments of 2022.
For each of fiscal years 2023 through 2027, after the adjustments under paragraphs (2), (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
1 month of operating reserves maintained pursuant to 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).
The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of device applications.
The Secretary may use unobligated carryover balances from fees collected in previous fiscal years to ensure that sufficient fee revenues are available in that fiscal year, so long as the Secretary maintains unobligated carryover balances of not less than 1 month of operating reserves for the first month of the next fiscal year.
Not later than 14 days before the Secretary anticipates the use of funds described in subparagraph (A), the Secretary shall provide notice to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives.
The Secretary shall grant a waiver of the fee required under subsection (a) for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term “small business” means an entity that reported $30,000,000 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. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vii) and clauses (ix), (x), and (xi) of subsection (a)(2)(A) may be paid at a reduced rate in accordance with paragraph (2)(C).
For purposes of this paragraph, the term “small business” means an entity that reported $100,000,000 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.
An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for a waiver of the fee or the lower fee rate.
The applicant shall support its claim that it meets the definition under subparagraph (A) 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 subparagraph (A). The applicant, 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 applicant shall certify that the applicant has no affiliates.
In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant 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 applicant 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 applicant’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 applicant shall also submit a statement signed by the head of the applicant’s firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.
Where 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—
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
50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.
An applicant seeking a fee waiver or reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a waiver or reduction is not reviewable.
For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved is a small business, the fee specified in subsection (a)(2)(A)(viii) may be paid at a reduced rate in accordance with paragraph (2)(C).
For purposes of this subsection, the term “small business” means an entity that reported $100,000,000 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.
An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for the lower fee rate.
The applicant shall support its claim that it meets the definition under subparagraph (A) 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 subparagraph (A). The applicant, 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 applicant shall certify that the applicant has no affiliates.
In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant 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 applicant 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 applicant’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 applicant shall also submit a statement signed by the head of the applicant’s firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.
For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 25 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection (c)(1).
An applicant seeking a fee reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a reduction is not reviewable.
A 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 submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.
Registration information submitted under section 360 of this title by an establishment subject to a registration fee shall be considered incomplete and shall not be accepted by the Secretary until the registration fee under subsection (a)(3) owed for the establishment has been paid. Until the fee is paid and the registration is complete, the establishment is deemed to have failed to register in accordance with section 360 of this title.
With 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—
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
fees were not assessed under subsection (a) for the previous fiscal year.
If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, de novo classification requests, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
Beginning on October 1, 2023, the authorities under section 379i(10)(C) of this title shall include only leasing and necessary scientific equipment.
Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of device applications.
The fees authorized by this section—
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
shall be available—
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
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.
The 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—
are not more than 3 percent below the level specified in subparagraph (A)(ii); or
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
such costs are not more than 5 percent below the level specified in such subparagraph.
To the extent such costs are more than 5 percent below the specified level in subparagraph (A)(ii), fees may not be collected under this section for that fiscal year.
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
For each of fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined under subparagraph (B), less the amount of reductions determined under 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 paragraphs (2) and (3) of subsection (c); and
the performance improvement adjustment amount for the fiscal year under subsection (c)(4), 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.
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.
To qualify for consideration for a refund under subsection (a)(2)(D), a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due.
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of device applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
Source credit: (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.)
- 1938Enacted · Pub. L. 107-250 · 116 Stat. 1591
- 2004Amended · Pub. L. 108-214 · 118 Stat. 572, 576, 577
- 2005Amended · Pub. L. 109-43 · 119 Stat. 439
- 2007Amended · Pub. L. 110-85 · 121 Stat. 844
- 2012Amended · Pub. L. 112-144 · 126 Stat. 1002
- 2012Amended · Pub. L. 112-193 · 126 Stat. 1443
- 2017Amended · Pub. L. 115-52 · 131 Stat. 1013
- 2022Amended · Pub. L. 117-180 · 136 Stat. 2148
- 2022Amended · Pub. L. 117-328 · 136 Stat. 5836, 5882
A history note hasn’t been published yet. The record shows enactment by Pub. L. 107-250 on 1938-06-25.
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