{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance entitled \"Use of Real- World Evidence to Support Regulatory Decision-Making for Medical Devices.\" FDA is issuing this guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This final guidance supersedes the final guidance, \"Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,\" issued August 31, 2017, and provides expanded and updated recommendations.","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/2025/12/18/2025-23252.html","cfr_references":[],"citation":"90 FR 59127","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on December 18, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-4395"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2025-12-18T08:57:18.046-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-4395-0033","allow_late_comments":false,"id":"FDA-2023-D-4395-0033","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-4395","title":"Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2025-23252","effective_on":null,"end_page":59129,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/12/18/2025-23252.xml","html_url":"https://www.federalregister.gov/documents/2025/12/18/2025-23252/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-23252?publication_date=2025-12-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-12-18/2025-23252/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3779,"last_updated":"2026-09-21 12:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-18/pdf/2025-23252.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23252.pdf?1765979123","publication_date":"2025-12-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/12/18/2025-23252.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-D-4395","supporting_documents_count":0,"docket_id":"FDA-2023-D-4395","document_id":"FDA-2023-D-4395-0033","regulation_id_number":null,"title":"Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2025-12-19T17:55:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59127,"subtype":null,"title":"Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}