{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing a virtual public meeting entitled \"Medical Device User Fee Amendments.\" The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2023 through 2027. MDUFA authorizes FDA to collect fees and use them for the process for the review of device applications. The current legislative authority for MDUFA expires September 30, 2022. At that time, new legislation will be required for FDA to continue collecting device user fees in future fiscal years. Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.","action":"Notice of public meeting; request for comments.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2022/04/07/2022-07451.html","cfr_references":[],"citation":"87 FR 20436","comment_url":null,"comments_close_on":"2022-04-21","correction_of":null,"corrections":[],"dates":"The public meeting will be held virtually on April 19, 2022, from 12 p.m. to 4:30 p.m. Eastern Time. Submit electronic or written comments to the public docket by April 21, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-0907"],"dockets":[{"supporting_documents":[{"title":"Final Transcripts of the Medical Device User Fee Amendment Reauthorization meeting held on April 19 - MEDICAL DEVICE USER FEE AMENDMENTS FOR FISCAL YEARS 2023 THROUGH 2027","document_id":"FDA-2020-N-0907-0052"},{"title":"Medical Device User Fee Amendments; Public Meeting; Request for Comments","document_id":"FDA-2020-N-0907-0041"},{"title":"MDUFA V - Draft Commitment Letter","document_id":"FDA-2020-N-0907-0040"},{"title":"Final Transcripts from the MDUFA V Meeting","document_id":"FDA-2020-N-0907-0039"},{"title":"Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027;\nPublic Meeting; Request for Comments","document_id":"FDA-2020-N-0907-0013"},{"title":"Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments; Postponement","document_id":"FDA-2020-N-0907-0005"},{"title":"Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027;\nPublic Meeting; Request for Comments","document_id":"FDA-2020-N-0907-0003"},{"title":"Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027;\nPublic Meeting; Request for Comments","document_id":"FDA-2020-N-0907-0001"}],"agency_name":null,"documents":[{"comment_count":7,"comment_start_date":"2022-04-07","updated_at":"2023-02-28T12:20:19.996-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-0907-0041","allow_late_comments":null,"id":"FDA-2020-N-0907-0041","comment_end_date":"2022-04-22","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":8,"id":"FDA-2020-N-0907","title":"Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments"}],"document_number":"2022-07451","effective_on":null,"end_page":20441,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/04/07/2022-07451.xml","html_url":"https://www.federalregister.gov/documents/2022/04/07/2022-07451/medical-device-user-fee-amendments-public-meeting-request-for-comments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-07451?publication_date=2022-04-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-04-07/2022-07451/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":1388,"last_updated":"2026-10-23 02:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-04-07/pdf/2022-07451.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-07451.pdf?1649249143","publication_date":"2022-04-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/04/07/2022-07451.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Final Transcripts of the Medical Device User Fee Amendment Reauthorization meeting held on April 19 - MEDICAL DEVICE USER FEE AMENDMENTS FOR FISCAL YEARS 2023 THROUGH 2027","document_id":"FDA-2020-N-0907-0052"},{"title":"Medical Device User Fee Amendments; Public Meeting; Request for Comments","document_id":"FDA-2020-N-0907-0041"},{"title":"MDUFA V - Draft Commitment Letter","document_id":"FDA-2020-N-0907-0040"},{"title":"Final Transcripts from the MDUFA V Meeting","document_id":"FDA-2020-N-0907-0039"},{"title":"Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027;\nPublic Meeting; Request for Comments","document_id":"FDA-2020-N-0907-0013"},{"title":"Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments; Postponement","document_id":"FDA-2020-N-0907-0005"},{"title":"Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027;\nPublic Meeting; Request for Comments","document_id":"FDA-2020-N-0907-0003"},{"title":"Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027;\nPublic Meeting; Request for Comments","document_id":"FDA-2020-N-0907-0001"}],"comments_count":7,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-0907","supporting_documents_count":8,"docket_id":"FDA-2020-N-0907","document_id":"FDA-2020-N-0907-0041","regulation_id_number":null,"title":"Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments","checked_regulationsdotgov_at":"2023-02-28T17:20:19Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20436,"subtype":null,"title":"Medical Device User Fee Amendments; Public Meeting; Request for Comments","toc_doc":"Medical Device User Fee Amendments","toc_subject":"Meetings","topics":[],"type":"Notice","volume":87}