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GUIDANCE DOCUMENT

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

Final
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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.