FDA Watch Podcast Taps Cathy Burgess for Insights on Medical Device Regulation

Cathy Burgess, partner and head of Alston & Bird’s FDA: Compliance & Enforcement Team, joined an FDA Watch Podcast episode, “Keeping Up with Medical Device Manufacturing and Digital Health,” to examine the changing regulatory landscape for medical devices. She discussed developments at the Center for Devices and Radiological Health, implementation of the Quality Management System Regulation, new cybersecurity requirements, developments in digital health, the next user fee authorization, and risks associated with artificial intelligence in medical devices.