FDA Updates Its Human Factors Guidance: What Changed and What It Means for Device Developers
August 6, 2026
Focus area
Human factors and usability
Usability engineering for medical devices and SaMD under IEC 62366-1 and FDA human factors guidance, from use-related risk analysis to validation.
How we help
Use-related risk analysis
URRA and critical task identification tied to your ISO 14971 risk file.
Formative evaluations
Early studies that find use problems while design changes are still inexpensive.
Validation testing
Human factors validation protocols and reports built around critical tasks.
Submission content
Scoping the human factors section of a 510(k), De Novo or PMA under FDA's 2026 guidance.
