FDA GUIDANCE · FINALJanuary 13, 2025

Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA 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

Issue date

January 13, 2025

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