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GUIDANCE DOCUMENT

Real-Time Premarket Approval Application (PMA) Supplements Guidance for Industry and FDA Staff April 2006

Final
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance provides information about the real-time review process for premarket approval application (PMA) supplements and outlines the procedures for requesting and submitting these types of documents. This guidance supersedes the document entitled "Real-Time" Review Program for Premarket Approval Application (PMA) Supplements, issued April 22, 1997 (the 1997 document) and Section II C, “PMA Supplements Definitions – Real Time Supplements” of the February 2003 guidance entitled, “Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and FDA.”


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.