{"url_path":"/register/2026-05-29/2026-10734","section_key":"summary","section_title":"Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability","topic":"register","document":{"doc_type":"Notice","doc_date":"2026-05-29","source_url":"https://www.federalregister.gov/documents/2026/05/29/2026-10734/content-of-human-factors-information-in-medical-device-marketing-submissions-guidance-for-industry","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Health and Human Services Department"},"word_count":107,"has_tables":false,"body_markdown":"# Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability\n\n**Type:** Notice\n**Published:** 2026-05-29\n**Citation:** 91 FR 32061\n**Agencies:** Health and Human Services Department, Food and Drug Administration\n**Source:** https://www.federalregister.gov/documents/2026/05/29/2026-10734/content-of-human-factors-information-in-medical-device-marketing-submissions-guidance-for-industry\n\n## Abstract\nThe 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."}