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GUIDANCE DOCUMENT

Premarket Approval Application Modular Review Guidance for Industry and FDA Staff November 2003

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The purpose of this guidance document is to provide industry and FDA staff with information regarding the premarket approval application (PMA) modular review program and to outline the procedures for submitting or reviewing a modular PMA.

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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-2020-D-0957.

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