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GUIDANCE DOCUMENT

Premarket Approval Application and Humanitarian Device Exemption Modular Review Guidance for Industry and FDA Staff January 2025

Download the Final Guidance Document
Final
Docket Number:
FDA-2024-D-5332
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
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.

Submit Comments

Submit Comments Online

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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