This session is dedicated to FDA regulation of digital health products, from traditional software-based medical devices to novel medical device software functions deployed on consumer products or wearables. Participants will join FDA leaders in a discussion about expectations for implementing artificial intelligence/machine learning, Predetermined Change Control Plans (PCCPs), and other digital health guidance or policy updates.

Jennifer Kozen
Assistant Director of the External Heart Rhythm and Rate Devices Team
US Food & Drug Administration

Stephen Browning
Assistant Division Director
US Food & Drug Administration

Robert Kazmierski
Lead Reviewer
US Food & Drug Administration

Luke Ralston
Biomedical Engineer
US Food & Drug Administration