{"abstract":"The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot that will begin in fiscal year (FY) 2023 with the initial phase, hereafter referred to as the TAP Pilot Soft Launch. The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the reauthorization of the Medical Device User Fee Amendments for FY 2023 through FY 2027 (MDUFA V). The long-term vision for TAP is to help spur more rapid development and more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance. Over the course of MDUFA V, the voluntary TAP Pilot is intended to demonstrate the feasibility and benefits of process improvements to FDA's early interactions with participants and of FDA's facilitation of interactions between participants and stakeholders that support the vision for TAP.","action":"Notice; 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/2022/10/12/2022-21835.html","cfr_references":[],"citation":"87 FR 61605","comment_url":null,"comments_close_on":"2023-01-10","correction_of":null,"corrections":[],"dates":"Beginning January 1, 2023, FDA is seeking requests for enrollment in the TAP Pilot Soft Launch for FY 2023. Either electronic or written comments on this notice must be submitted by January 10, 2023 to ensure that the Agency considers your comment on this notice before it begins work on the next phase of the TAP Pilot.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-2274"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":5,"comment_start_date":"2022-10-12","updated_at":"2023-02-27T20:10:38.194-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-2274-0001","allow_late_comments":null,"id":"FDA-2022-N-2274-0001","comment_end_date":"2023-01-11","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-N-2274","title":"TPLC Advisory Program Pilot Soft Launch"}],"document_number":"2022-21835","effective_on":null,"end_page":61608,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/10/12/2022-21835.xml","html_url":"https://www.federalregister.gov/documents/2022/10/12/2022-21835/medical-devices-voluntary-total-product-life-cycle-advisory-program-pilot","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-21835?publication_date=2022-10-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-10-12/2022-21835/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":4595,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-10-12/pdf/2022-21835.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-21835.pdf?1665492317","publication_date":"2022-10-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/10/12/2022-21835.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":5,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-N-2274","supporting_documents_count":0,"docket_id":"FDA-2022-N-2274","document_id":"FDA-2022-N-2274-0001","regulation_id_number":null,"title":"TPLC Advisory Program Pilot Soft Launch","checked_regulationsdotgov_at":"2023-02-28T01:10:37Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":61605,"subtype":null,"title":"Medical Devices; Voluntary Total Product Life Cycle Advisory Program Pilot","toc_doc":"Medical Devices; Voluntary Total Product Life Cycle Advisory Program Pilot","toc_subject":null,"topics":[],"type":"Notice","volume":87}