Premarket Approval Application and Humanitarian Device Exemption Modular Review (January 2025 Draft guidance for Industry and FDA)
Docket Number:FDA-2024-D-5332
Issued by: Center for Devices and Radiological Health and Center for Biologics Evaluation and Research
This guidance provides information on the Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) modular review program and the procedures for submitting or reviewing a modular PMA or HDE.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)). If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document’s docket number: FDA-2024-D-5332.
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