Issue Date: December 16, 2019
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Administrative / Procedural, Device & Drug Safety, Premarket Approval (PMA)
Status: Final
Real-Time Premarket Approval Application (PMA) Supplements: Guidance for Industry and FDA Staff
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 .”
Download the Guidance Document
