{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"510(k) Third Party Review Program.\" This guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third Party (3P510k) Review Program authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FDA Reauthorization Act of 2017 (FDARA), FDA was directed to issue guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person. The 3P510k Review Program is intended to allow review of devices by 3P510k Review Organizations in order to provide manufacturers of these devices an alternative review process that allows FDA to best utilize our resources on higher risk devices.","action":"Notice of availability.","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/2020/03/12/2020-05080.html","cfr_references":[],"citation":"85 FR 14489","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on March 12, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-2565"],"dockets":[],"document_number":"2020-05080","effective_on":null,"end_page":14491,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/03/12/2020-05080.xml","html_url":"https://www.federalregister.gov/documents/2020/03/12/2020-05080/the-510k-third-party-review-program-guidance-for-industry-food-and-drug-administration-staff-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-05080?publication_date=2020-03-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-03-12/2020-05080/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":474,"last_updated":"2026-04-04 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-03-12/pdf/2020-05080.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-05080.pdf?1583930734","publication_date":"2020-03-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/03/12/2020-05080.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 3 - FDA Draft Guidance entitled Accreditation and Reaccreditation Process for Firms under the Third Party Review Program Part I_ 2013 re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability","document_id":"FDA-2016-D-2565-0004"},{"title":"Reference 2 - International Medical Device Regulators Forum’s Medical Device Single Audit Program documents re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability","document_id":"FDA-2016-D-2565-0003"},{"title":"Reference 1 - List of References for Third Party Review Program Draft Guidance re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability","document_id":"FDA-2016-D-2565-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-D-2565","supporting_documents_count":3,"docket_id":"FDA-2016-D-2565","regulation_id_number":null,"title":"510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability","checked_regulationsdotgov_at":"2020-03-16T03:00:19Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14489,"subtype":null,"title":"The 510(k) Third Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":85}