{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled \"Content of Human Factors Information in Medical Device Marketing Submissions.\" This guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be included in a marketing submission to the Center for Devices and Radiological Health (CDRH) to facilitate the efficiency of the FDA review process.","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/2026/05/29/2026-10734.html","cfr_references":[],"citation":"91 FR 32061","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 29, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-4599"],"dockets":[],"document_number":"2026-10734","effective_on":null,"end_page":32062,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/29/2026-10734.xml","html_url":"https://www.federalregister.gov/documents/2026/05/29/2026-10734/content-of-human-factors-information-in-medical-device-marketing-submissions-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-10734?publication_date=2026-05-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-29/2026-10734/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":320,"last_updated":"2026-05-31 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-29/pdf/2026-10734.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10734.pdf?1779972320","publication_date":"2026-05-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/29/2026-10734.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2026-05-29T09:02:34Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":32061,"subtype":null,"title":"Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Content of Human Factors Information in Medical Device Marketing Submissions","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}