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    • MEDICAL DEVICES—FDA GUIDANCE NOTICES: Content of human factors information in medical device marketing submissions guidance issued
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    Health Law Daily Wrap Up, MEDICAL DEVICES—FDA GUIDANCE NOTICES: Content of human factors information in medical device marketing submissions guidance issued, (Jun 1, 2026)

    By WK Editorial Staff

    The purpose of the guidance is to facilitate the efficiency of the FDA review process.

    The FDA issued a final guidance titled “Content of Human Factors Information in Medical Device Marketing Submissions” that provides a risk-based frame ...

    By WK Editorial Staff

    The purpose of the guidance is to facilitate the efficiency of the FDA review process.

    The FDA issued a final guidance titled “Content of Human Factors Information in Medical Device Marketing Submissions” that 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. The final guidance is intended to be used to complement the FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” (Notice, 91 Fed. Reg. 32061 (May 29, 2026)).

    Dates. The announcement of the guidance is published in the Federal Register on May 29, 2026.

    FederalRegisterIssuances: FDAGuidanceNotices FDCActNews MDeviceNews

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