USC Subpart 3

USC Subpart 3
in effect

21 U.S.C. § 379i Definitions

For purposes of this subpart: (1) The term “premarket application” means—(A) an application for approval of a device submitted under section 360e(c) of this title or section 262 of title 42; or (B) a product development protocol described in section 360e(f) of this title. Such term does not include a supplement, a premarket report, or a premarket notification submission. (2) The term “premarket report” means a report submitted under section 360e(c)(2) of this title. (3) The term “premarket notification submission” means a report submitted under section 360(k) of this title. (4)(A) The term “supplement”, with respect to a panel-track supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which—(i) an application or report has been approved under section 360e(d) of this title, or an application has been approved under section 262 of title 42; or (ii) a notice of completion has become effective under section 360e(f) of this title. (B) The term “panel-track supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness. (C) The term “180-day supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling. (D) The term “real-time supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement. (E) The term “efficacy supplement” means a supplement to an approved premarket application under section 262 of title 42 that requires substantive clinical data. (5) The term “30-day notice” means a notice under section 360e(d)(5) of this title that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device. (6) The term “request for classification information” means a request made under section 360c(g) of this title for information respecting the class in which a device has been classified or the requirements applicable to a device. (7) The term “annual fee”, for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order. (8) The term “de novo classification request” means a request made under section 360c(f)(2)(A) of this title with respect to the classification of a device. (9) The term “process for the review of device applications” means the following activities of the Secretary with respect to the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests:(A) The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions. (B) The issuance of action letters that allow the marketing of devices or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to place them in condition for approval. (C) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary’s review of pending premarket applications, premarket reports, and supplements. (D) Monitoring of research conducted in connection with the review of such applications, reports, supplements, submissions, and de novo classification requests. (E) Review of device applications subject to section 262 of title 42 for an investigational new drug application under section 355(i) of this title or for an investigational device exemption under section 360j(g) of this title and activities conducted in anticipation of the submission of such applications under section 355(i) or 360j(g) of this title. (F) The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests. (G) The development of voluntary test methods, consensus standards, or mandatory performance standards under section 360d of this title in connection with the review of such applications, reports, supplements, submissions, or requests and related activities. (H) The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, submissions, or requests. (I) Any activity undertaken under section 360c or 360e(i) of this title in connection with the initial classification or reclassification of a device or under section 360e(b) of this title in connection with any requirement for approval of a device. (J) Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42. (K) Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, premarket notification submissions, or de novo classification requests. (10) The term “costs of resources allocated for the process for the review of device applications” means the expenses in connection with the process for the review of device applications for—(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors; (B) management of information, and the acquisition, maintenance, and repair of computer resources; (C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and (D) collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, submissions, and de novo classification requests. (11) The term “adjustment factor” applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2021. (12) The term “person” includes an affiliate thereof. (13) The term “affiliate” means a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly—(A) one business entity controls, or has the power to control, the other business entity; or (B) a third party controls, or has power to control, both of the business entities. (14) The term “establishment subject to a registration fee” means an establishment that is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.

21 U.S.C. § 379j Authority to assess and use device fees

(a) Types of fees(1) In generalBeginning 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 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 exemptionAn application under section 360j(m) of this title is not subject to any fee under subparagraph (A). (ii) Further manufacturing useNo 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 sponsorsNo 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 partiesNo 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 generalNo 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 useIn 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) PaymentThe 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 filingThe 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 filingThe 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 actionAfter 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 actionThe 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 applicationsIf 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 refundThe 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 generalExcept 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 generalNo 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 businessFor 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) WaiverThe 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 ServiceThe 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 ServiceIn 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 waiverAn 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) PaymentThe 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 generalSubject 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 specifiedFor 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 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. (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 generalThe 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 amountsFor 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 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. (C) Base inflation adjustment(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 feesFor 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 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 definedFor 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(A) In generalFor each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2), (3), and (4), if applicable, if the number of hires to support the process for the review of device applications falls below the thresholds specified in subparagraph (B) for the applicable fiscal years, the base establishment registration fee amounts shall be decreased as the Secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph (C). (B) 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 hiresFor 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. (6) Operating reserve adjustment(A) In generalFor 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. (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). (C) Excluded amountFor 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). (7) LimitThe 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. (8) Supplement(A) In generalThe 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. (B) Notice to CongressNot 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. (d) Small businesses; fee waiver and fee reduction regarding premarket approval fees(1) In generalThe 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). (2) Rules relating to premarket approval fees(A) DefinitionFor 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. (B) Evidence of qualification(i) In generalAn 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. (ii) Firms submitting tax returns to the United States Internal Revenue ServiceThe 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. (iii) Firms not submitting tax returns to the United States Internal Revenue ServiceIn 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. (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 reductionAn 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. (e) Small businesses; fee reduction regarding premarket notification submissions(1) In generalFor 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). (2) Rules relating to premarket notification submissions(A) DefinitionFor 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. (B) Evidence of qualification(i) In generalAn 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. (ii) Firms submitting tax returns to the United States Internal Revenue ServiceThe 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. (iii) Firms not submitting tax returns to the United States Internal Revenue ServiceIn 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. (C) Reduced feesFor 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). (D) Request for reductionAn 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. (f) Effect of failure to pay fees(1) No acceptance of submissionsA 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. (2) No registrationRegistration 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. (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) AuthorityIf 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. (3) LimitationBeginning on October 1, 2023, the authorities under section 379i(10)(C) of this title shall include only leasing and necessary scientific equipment. (h) Crediting and availability of fees(1) In generalSubject 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. (2) Collections and appropriation acts(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 percentTo 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. (C) Provision for early paymentsPayment 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. (3) Authorization of appropriations(A) In generalFor 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). (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. (C) Amount of reductionsFor purposes of this paragraph, the amount of reductions for each fiscal year is the sum of—(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 feesIn 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. (j) Written requests for refundsTo 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. (k) ConstructionThis 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.

21 U.S.C. § 379j–1 Reauthorization; reporting requirements

(a) Reports(1) Performance report(A) In general(i) General requirementsBeginning with fiscal year 2023, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) 11 See References in Text note below. of the Medical Device User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. (ii) Additional informationBeginning with fiscal year 2023, the annual report under this subparagraph shall include the progress of the Center for Devices and Radiological Health in achieving the goals, and future plans for meeting the goals, including—(I) the number of premarket applications filed under section 360e of this title per fiscal year for each review division; (II) the number of reports submitted under section 360(k) of this title per fiscal year for each review division; (III) the number of expedited development and priority review designations under section 360e–3 1 of this title per fiscal year; (IV) the number of investigational device exemption applications submitted under section 360j(g) of this title per fiscal year, including for each review division; and (V) the number of expedited development and priority review requests and designations under section 360e–3 of this title per fiscal year, including for each review division. Nothing in this clause shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5. (iii) Real time reporting(I) In generalNot later than 30 calendar days after the end of the second quarter of fiscal year 2023, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subclause (II) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual report under this subparagraph. (II) DataThe Secretary shall post the following data in accordance with subclause (I):(aa) The number and titles of draft and final guidance on topics related to the process for the review of devices, and whether such guidances were issued as required by statute or pursuant to the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022; and (bb) The number and titles of public meetings held on topics related to the process for the review of devices, and if such meetings were required by statute or pursuant to a commitment under the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022. (iv) Rationale for MDUFA program changesBeginning with fiscal year 2023, the Secretary shall include in the annual report under paragraph (1)—(I) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379j of this title, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; (II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of device applications, including identifying—(aa) drivers of such changes; and (bb) changes in the average total cost per full-time equivalent in the medical device review program; (III) for each of the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and (IV) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of medical device application types. (v) AnalysisFor each fiscal year, the Secretary shall include in the report under clause (i) an analysis of the following:(I) The difference between the aggregate number of premarket applications filed under section 360e of this title and aggregate reports submitted under section 360(k) of this title and the aggregate number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for—(aa) the number of applications filed and reports submitted during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and (bb) the aggregate number of applications for each fiscal year that did not meet the goals as identified by the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year. (II) Relevant data to determine whether the Center for Devices and Radiological Health has met performance enhancement goals identified by the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year. (III) The most common causes and trends for external or other circumstances affecting the ability of the Center for Devices and Radiological Health, the Office of Regulatory Affairs, or the Food and Drug Administration to meet review time and performance enhancement goals identified by the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022. (B) PublicationWith regard to information to be reported by the Food and Drug Administration to industry on a quarterly and annual basis pursuant to the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022, the Secretary shall make such information publicly available on the Internet Web site of the Food and Drug Administration not later than 60 days after the end of each quarter or 120 days after the end of each fiscal year, respectively, to which such information applies. This information shall include the status of the independent assessment identified in the letters described in such section 201(b). (C) UpdatesThe Secretary shall include in each report under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort. (2) Corrective action reportBeginning with fiscal year 2023, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:(A) Goals metFor each fiscal year, if the Secretary determines, based on the analysis under paragraph (1)(A)(iv), that each of the goals identified by the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the medical device application review process. (B) Goals missedFor each of the goals identified by the letters described in section 201(b) 1 of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—(i) a justification for such determination; (ii) a description of the types of circumstances, in the aggregate, under which applications or reports submitted under section 360e of this title or notifications submitted under section 360(k) of this title missed the review goal times but were approved during the first cycle review, as applicable; (iii) a summary and any trends with regard to the circumstances for which a review goal was missed; and (iv) the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such 22 So in original. fiscal year. (3) Enhanced communication(A) Communications with CongressEach fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of devices shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section. (B) Participation in congressional hearingEach fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart. (4) Fiscal reportFor fiscal years 2023 through 2027, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made. (5) Public availabilityThe Secretary shall make the reports required under paragraphs (1) and (2) available to the public on the Internet Web site of the Food and Drug Administration. (b) Reauthorization(1) ConsultationIn developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of device applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—(A) the Committee on Energy and Commerce of the House of Representatives; (B) the Committee on Health, Education, Labor, and Pensions of the Senate; (C) scientific and academic experts; (D) health care professionals; (E) representatives of patient and consumer advocacy groups; and (F) the regulated industry. (2) Prior public inputPrior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—(A) publish a notice in the Federal Register requesting public input on the reauthorization; (B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a)(1); (C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and (D) publish the comments on the Food and Drug Administration’s Internet Web site. (3) Periodic consultationNot less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2). (4) Updates to CongressThe Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. (5) Public review of recommendationsAfter negotiations with the regulated industry, the Secretary shall—(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph; (B) publish such recommendations in the Federal Register; (C) provide for a period of 30 days for the public to provide written comments on such recommendations; (D) hold a meeting at which the public may present its views on such recommendations; and (E) after consideration of such public views and comments, revise such recommendations as necessary. (6) Transmittal of recommendationsNot later than January 15, 2027, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments. (7) Minutes of negotiation meetings(A) Public availabilityThe Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting. (B) ContentThe minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

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