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

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

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

May 29, 2026

May 28, 2026

Center for Devices and Radiological Health

08b681b2-5a56-4038-8e63-d7363bb78154

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