Device Safety and the FDA with Drs Ronald Fairman and Carmen Johnson

We are excited to share our discussion with Dr. Carmen Johnson and Dr. Ronald Fairman from the Food and Drug Administration on the approval processes and the post-market surveillance of medical devices. 

Dr. Carmen Gacchina Johnson is the Assistant Director, Vascular & Endovascular Devices at the Food and Drug Administration. She has a Ph.D. in Bioengineering and has been with the FDA since 2012. Her area of expertise is in cardiovascular devices. 

Dr. Ronald Fairman is an Emeritus Professor of Surgery and former Chief of the Division of Vascular Surgery at the University of Pennsylvania, as well as a former President of the Society for Vascular Surgery. He is speaking to us today in his role as Medical Officer on the Vascular and Endovascular Devices Team (VEDT)

A History of Medical Device Regulation & Oversight in the United States

MedWatch Forms for FDA Safety Reporting

Virtual two-day meeting of the CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee in Quarter4 of 2021

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** Leadership Development Program Applications are open and due by July 16, 2021 **