Modernizing the FDA Premarket Approval Process for Medical Devices

Host: Jack Lewin, MD Guest: Rita Redberg, MD, MSc Guest: Bram Zuckerman, MD The FDA's premarket approval (or PMA) process was first established over 30 years ago, but thanks to technology, the development of devices has dramatically changed since then. How should the FDA modernize its premarket approval process to ensure medical device safety? Guests Dr. Rita Redberg, professor of clinical medicine at the University of California, San Francisco, School of Medicine, and director of women's cardiovascular services at the U-C-S-F National Center for Excellence in Women's Health, and Dr. Bram Zuckerman, director of the division of cardiovascular devices at the FDA, discuss current and ongoing research about the quality of the FDA PMA process. Produced in Cooperation with