Collapse to view only § 379j-1. Reauthorization; reporting requirements
- § 379i. Definitions
- § 379j. Authority to assess and use device fees
- § 379j-1. Reauthorization; reporting requirements
§ 379i. DefinitionsFor 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)
(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.
(June 25, 1938, ch. 675, § 737, as added Pub. L. 107–250, title I, § 102(a), Oct. 26, 2002, 116 Stat. 1589; amended Pub. L. 108–214, § 2(a)(1), (d)(3)(A), Apr. 1, 2004, 118 Stat. 572, 577; Pub. L. 110–85, title II, § 211, Sept. 27, 2007, 121 Stat. 843; Pub. L. 112–144, title II, § 202, July 9, 2012, 126 Stat. 1002; Pub. L. 114–255, div. A, title III, § 3051(c)(2), Dec. 13, 2016, 130 Stat. 1124; Pub. L. 115–52, title II, § 202(a), Aug. 18, 2017, 131 Stat. 1013; Pub. L. 117–180, div. F, title II, § 2002, Sept. 30, 2022, 136 Stat. 2148.)
§ 379j. Authority to assess and use device fees
(a) Types of fees
(1) In general
(2) Premarket application, premarket report, supplement, and submission fee, and annual fee for periodic reporting concerning a class III device
(A) In generalExcept as provided in subparagraph (B) and subsections (d) and (e), each person who submits any of the following, on or after October 1, 2022, shall be subject to a fee established under subsection (c) for the fiscal year involved in accordance with the following:
(i) A premarket application.
(ii) For a premarket report, a fee equal to the fee that applies under clause (i).
(iii) For a panel track supplement, a fee equal to 80 percent of the fee that applies under clause (i).
(iv) For a 180-day supplement, a fee equal to 15 percent of the fee that applies under clause (i).
(v) For a real-time supplement, a fee equal to 7 percent of the fee that applies under clause (i).
(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).
(vii) For an efficacy supplement, a fee equal to the fee that applies under clause (i).
(viii) For a premarket notification submission, a fee equal to 4.5 percent of the fee that applies under clause (i).
(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i).
(x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).
(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).
(B) Exceptions
(i) Humanitarian device exemption
(ii) Further manufacturing use
(iii) State or Federal Government sponsors
(iv) Premarket notifications by third parties
(v) Pediatric conditions of use(I) In general(II) Subsequent proposal of adult conditions of use
(C) Payment
(D) Refunds
(i) Application refused for filing
(ii) Application withdrawn before filing
(iii) Application withdrawn before first action
(iv) Modular applications withdrawn before first action
(v) Later withdrawn modular applications
(vi) Sole discretion to refund
(3) Annual establishment registration fee
(A) In general
(B) Exception
(i) In general
(ii) Small businesses fee waiver(I) Definition of small business(II) Waiver(III) Firms submitting tax returns to the United States Internal Revenue Service(IV) Firms not submitting tax returns to the United States Internal Revenue Service(V) Request for waiver
(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 general
(2) Base fee amounts specified
(3) Total revenue amounts specifiedFor purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:
(A) $312,606,000 for fiscal year 2023.
(B) $335,750,000 for fiscal year 2024.
(C) $350,746,400 for fiscal year 2025.
(D) $366,486,300 for fiscal year 2026.
(E) $418,343,000 for fiscal year 2027.
(c) Annual fee setting; adjustments
(1) In general
(2) Inflation adjustments
(A) Adjustment to total revenue amounts
(B) Applicable inflation adjustmentThe applicable inflation adjustment for fiscal year 2023 and each subsequent fiscal year is the product of—
(i) the base inflation adjustment under subparagraph (C) for such fiscal year; and
(ii) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2022.
(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 fees
(4) Performance improvement adjustment
(A) In generalFor each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2) and (3), the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the Secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022, as the Secretary determines necessary to achieve an increase in total fee collections for such fiscal year equal to the following amounts, as applicable:
(i) For fiscal year 2025, the product of—(I) the amount determined under subparagraph (B)(i)(I); and(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.
(ii) For fiscal year 2026, the product of—(I) the sum of the amounts determined under subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.
(iii) For fiscal year 2027, the product of—(I) the sum of the amounts determined under subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.
(B) Amounts
(i) Presubmission amountFor purposes of subparagraph (A), with respect to the Presubmission Written Feedback goal, the amounts determined under this subparagraph are as follows:(I) For fiscal year 2025, $15,396,600 if such goal for fiscal year 2023 is met.(II) For fiscal year 2026:(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.(bb) $36,792,200 if such goal for fiscal year 2024 is met.(III) For fiscal year 2027:(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for each of fiscal years 2024 and 2025 is not met.(bb) $36,792,200 if such goal for fiscal year 2024 is met and such goal for fiscal year 2025 is not met.(cc) $40,572,600 if such goal for fiscal year 2025 is met.
(ii) De novo classification request amountFor purposes of subparagraph (A), with respect to the De Novo Decision goal, the amounts determined under this subparagraph are as follows:(I) For fiscal year 2026, $6,323,500 if such goal for fiscal year 2023 is met.(II) For fiscal year 2027:(aa) $6,323,500 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.(bb) $11,765,400 if such goal for fiscal year 2024 is met.
(iii) Premarket notification and premarket approval amountFor purposes of subparagraph (A), with respect to the 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal, the amounts determined under this subparagraph are as follows:(I) For fiscal year 2026, $1,020,000 if the 4 goals for fiscal year 2023 are met.(II) For fiscal year 2027:(aa) $1,020,000 if the 4 goals for fiscal year 2023 are met and one or more of the 4 goals for fiscal year 2024 are not met.(bb) $3,906,000 if the 4 goals for fiscal year 2024 are met.
(C) Performance calculationFor purposes of this paragraph, performance of the following goals shall be determined as specified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and based on data available, as follows:
(i) The performance of the Presubmission Written Feedback goal shall be based on data available as of—(I) for fiscal year 2023, March 31, 2024;(II) for fiscal year 2024, March 31, 2025; and(III) for fiscal year 2025, March 31, 2026.
(ii) The performance of the De Novo Decision goal, 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal shall be based on data available as of—(I) for fiscal year 2023, March 31, 2025; and(II) for fiscal year 2024, March 31, 2026.
(D) Goals defined
(5) Hiring adjustment
(A) In general
(B) ThresholdsThe thresholds specified in this subparagraph are as follows:
(i) For fiscal year 2025, the threshold is 123 hires for fiscal year 2023.
(ii) For fiscal year 2026, the threshold is 38 hires for fiscal year 2024.
(iii) For fiscal year 2027, the threshold is—(I) 22 hires for fiscal year 2025 if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i); or(II) 75 hires for fiscal year 2025 if such fees are so increased.
(C) Hiring adjustment amountThe hiring adjustment amount for fiscal year 2025 and each subsequent fiscal year is the product of—
(i) the number of hires by which the hiring goal specified in subparagraph (D) for the fiscal year before the prior fiscal year was not met;
(ii) $72,877; and
(iii) the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was not met.
(D) Hiring goalsThe hiring goals for each of fiscal years 2023 through 2025 are as follows:
(i) For fiscal year 2023, 144 hires.
(ii) For fiscal year 2024, 42 hires.
(iii) For fiscal year 2025:(I) 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i).(II) 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i).
(E) Number of hires
(6) Operating reserve adjustment
(A) In general
(B) Designated amountSubject to subparagraph (C), for each fiscal year, the designated amount in this subparagraph is equal to the sum of—
(i) 13 weeks of operating reserves of carryover user fees; and
(ii) 1 month of operating reserves maintained pursuant to paragraph (8).
(C) Excluded amount
(7) Limit
(8) Supplement
(A) In general
(B) Notice to Congress
(d) Small businesses; fee waiver and fee reduction regarding premarket approval fees
(1) In general
(2) Rules relating to premarket approval fees
(A) Definition
(B) Evidence of qualification
(i) In general
(ii) Firms submitting tax returns to the United States Internal Revenue Service
(iii) Firms not submitting tax returns to the United States Internal Revenue Service
(C) Reduced feesWhere the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—
(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, periodic reporting concerning a class III device, or a de novo classification request; and
(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.
(D) Request for fee waiver or reduction
(e) Small businesses; fee reduction regarding premarket notification submissions
(1) In general
(2) Rules relating to premarket notification submissions
(A) Definition
(B) Evidence of qualification
(i) In general
(ii) Firms submitting tax returns to the United States Internal Revenue Service
(iii) Firms not submitting tax returns to the United States Internal Revenue Service
(C) Reduced fees
(D) Request for reduction
(f) Effect of failure to pay fees
(1) No acceptance of submissions
(2) No registration
(g) Conditions
(1) Performance goals; termination of programWith respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if—
(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is more than 1 percent less than $398,566,000 multiplied by the adjustment factor applicable to such fiscal year; or
(B) fees were not assessed under subsection (a) for the previous fiscal year.
(2) Authority
(3) Limitation
(h) Crediting and availability of fees
(1) In general
(2)
(A) In generalThe fees authorized by this section—
(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and
(ii) shall be available—(I) for fiscal year 2023, to defray increases in the costs of the resources allocated for the process for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor; and(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connection with the process for the review of device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.
(B) Compliance
(i) In generalThe Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable—(I) are not more than 3 percent below the level specified in subparagraph (A)(ii); or(II)(aa) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for a subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and(bb) such costs are not more than 5 percent below the level specified in such subparagraph.
(ii) More than 5 percent
(C) Provision for early payments
(3) Authorization of appropriations
(A) In general
(B) Revenue amountFor purposes of this paragraph, the revenue amount for each fiscal year is the sum of—
(i) the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under paragraphs (2) and (3) of subsection (c); and
(ii) the performance improvement adjustment amount for the fiscal year under subsection (c)(4), if applicable.
(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 fees
(j) Written requests for refunds
(k) Construction
(June 25, 1938, ch. 675, § 738, as added Pub. L. 107–250, title I, § 102(a), Oct. 26, 2002, 116 Stat. 1591; amended Pub. L. 108–214, § 2(a)(2), (d)(2)(A), (B), (3)(A), Apr. 1, 2004, 118 Stat. 572, 576, 577; Pub. L. 109–43, § 2(a), Aug. 1, 2005, 119 Stat. 439; Pub. L. 110–85, title II, § 212, Sept. 27, 2007, 121 Stat. 844; Pub. L. 112–144, title II, § 203(a)–(f), July 9, 2012, 126 Stat. 1002; Pub. L. 112–193, § 2(b)(1), Oct. 5, 2012, 126 Stat. 1443; Pub. L. 115–52, title II, § 203(a)–(f)(1), (2)(B)–(i), title IX, § 905(b)(2), Aug. 18, 2017, 131 Stat. 1013–1016, 1090; Pub. L. 117–180, div. F, title II, § 2003, Sept. 30, 2022, 136 Stat. 2148; Pub. L. 117–328, div. FF, title III, §§ 3309, 3625(d), (e)(1), Dec. 29, 2022, 136 Stat. 5836, 5882.)
§ 379j–1. Reauthorization; reporting requirements
(a) Reports
(1) Performance report
(A) In general
(i) General requirements
(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 general(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) Publication
(C) Updates
(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 met
(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 2
2 So in original.
fiscal year.(3) Enhanced communication
(A) Communications with Congress
(B) Participation in congressional hearing
(4) Fiscal report
(5) Public availability
(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 consultation
(4) Updates to Congress
(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 recommendations
(7) Minutes of negotiation meetings
(A) Public availability
(B) Content
(June 25, 1938, ch. 675, § 738A, as added Pub. L. 110–85, title II, § 213, Sept. 27, 2007, 121 Stat. 850; amended Pub. L. 112–144, title II, § 204, July 9, 2012, 126 Stat. 1006; Pub. L. 115–52, title II, § 204, title IX, §§ 903(b), 904(b), Aug. 18, 2017, 131 Stat. 1016, 1078, 1083; Pub. L. 117–180, div. F, title II, § 2004, Sept. 30, 2022, 136 Stat. 2153; Pub. L. 117–328, div. FF, title III, § 3626(b), Dec. 29, 2022, 136 Stat. 5884.)