GUIDANCE DOCUMENT

Real-Time Premarket Approval Application (PMA) Supplements Guidance for Industry and FDA Staff December 2019

Final

Docket Number:: FDA-2017-D-5971
Issued by:: Guidance Issuing Office

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

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.”

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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
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All written comments should be identified with this document's docket number: FDA-2017-D-5971.