'Pma submission' presentation slideshows

What is the Format & Content for a Premarket Approval (PMA) Submission?

What is the Format & Content for a Premarket Approval (PMA) Submission?. Carole C. Carey BSEE, MEng carole.carey@fda.hhs.gov Director, International Staff US Food and Drug Administration (USFDA) Center for Devices and Radiological Health (CDRH). Learning Objectives.

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An FDA ten year review of clinical trials for approved Obstetrics and Gynecological medical devices Dipali Dave, MD 1 , Jill Brown, MD, MPH 2 , Beverly Gallauresi, RN, MPH 1

108 views • 1 slides