{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.\" FDA is issuing this draft guidance to clarify how FDA evaluates real- world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be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 This draft guidance proposes expanded recommendations to the 2017 guidance entitled \"Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.\" This draft guidance is not final nor is it for implementation at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2023/12/19/2023-27852.html","cfr_references":[],"citation":"88 FR 87782","comment_url":null,"comments_close_on":"2024-02-20","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by February 20, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-4395"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-12-19","updated_at":"2023-12-19T11:57:28.107-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-4395-0001","allow_late_comments":null,"id":"FDA-2023-D-4395-0001","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of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff;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":"2023-27852","effective_on":null,"end_page":87784,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/12/19/2023-27852.xml","html_url":"https://www.federalregister.gov/documents/2023/12/19/2023-27852/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-draft-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-27852?publication_date=2023-12-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-12-19/2023-27852/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2955,"last_updated":"2026-10-23 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-12-19/pdf/2023-27852.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-27852.pdf?1702907132","publication_date":"2023-12-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/12/19/2023-27852.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-4395-0001","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":"2023-12-20T16:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":87782,"subtype":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","toc_doc":"Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}