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FDA GUIDANCE · FINALMay 29, 2026

Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status
Final
Topic
Premarket, Safety - Issues, Errors, and Problems
Issue date
May 29, 2026
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