{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.\" The Patient Engagement Advisory Committee (PEAC) recommended that FDA and industry develop a framework to clarify how patient advisors can engage in the clinical investigation process. This guidance focuses on the applications, perceived barriers, and common challenges of patient engagement in the design and conduct of medical device clinical studies.","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/2022/01/26/2022-01374.html","cfr_references":[],"citation":"87 FR 4036","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on January 26, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-3846"],"dockets":[],"document_number":"2022-01374","effective_on":null,"end_page":4037,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/01/26/2022-01374.xml","html_url":"https://www.federalregister.gov/documents/2022/01/26/2022-01374/patient-engagement-in-the-design-and-conduct-of-medical-device-clinical-studies-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-01374?publication_date=2022-01-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-01-26/2022-01374/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":811,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-01-26/pdf/2022-01374.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-01374.pdf?1643118326","publication_date":"2022-01-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/01/26/2022-01374.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-2019-D-3846","supporting_documents_count":0,"docket_id":"FDA-2019-D-3846","document_id":"FDA-2019-D-3846-0012","regulation_id_number":null,"title":"Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff, and Other Stakeholders; Availability","checked_regulationsdotgov_at":"2022-01-27T04:30:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":4036,"subtype":null,"title":"Patient Engagement in the Design and Conduct of Medical Device Clinical Studies; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability","toc_doc":"Patient Engagement in the Design and Conduct of Medical Device Clinical Studies","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}