Streamlined PMA Pilot Extends To DRAERD; Modular PMA Guidance Issued
This article was originally published in The Gray Sheet
FDA's streamlined premarket approval application review program will soon be piloted in the Division of Reproductive, Abdominal, Ear, Nose & Throat, and Radiological Devices in FDA's Office of Device Evaluation, agency topsiders say.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.