View all text of Subpart 3 [§ 379i - § 379j-1]
§ 379j–1. Reauthorization; reporting requirements
(a) Reports
(1) Performance report
(A) In general
(i) General requirements
(ii)Beginning 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.)