← FDA GUIDANCE
FDA GUIDANCE · FINALAugust 3, 2026

Applying Human Factors and Usability Engineering to Medical Devices: 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
Postmarket, Premarket, Safety - Issues, Errors, and Problems
Issue date
August 3, 2026
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