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 To sign up for news about device approvals, recalls, and other FDA actions and announcements, we recommend subscribing to CDRH News. ** Leadership Development Program Applications are open and due by July 16, 2021 ** What other topics would you like to hear about? Let us know more about you and what you think of our podcast through our Listener Survey or email us at AudibleBleeding@vascularsociety.org. Follow us on Twitter @audiblebleeding Learn more about us at https://www.audiblebleeding.com/about-1/ and #jointheconversation.