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FDA 101

September 21, 2023 | 03:15 PM (PST) - 04:15 PM (PST)

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Speakers
Gloria Nyankima
Biomedical Engineer at the Digital Health Center of Excellence
Food and Drug Administration (FDA)
Matthew Hazelett
Cybersecurity Policy Analyst
Food and Drug Administration (FDA) | Implantable Electrophysiology Devices Branch (IEDB) at the Center for Devices and Radiological Health (CDRH)
Aneesh Deoras
Assistant Director for Cardiac Ablation, Mapping, and Imaging Devices
FDA’s Office of Cardiovascular Devices, Center for Devices and Radiological Health
Stephen Browning
Assistant Director - Blood Pressure and Flow Devices
Food and Drug Administration (FDA)
Robert Kazmierski
Team Lead of the Hemodynamics and Heart Failure Devices Team
FDA’s Office of Cardiovascular Devices, Center for Devices and Radiological Health
Moderators
Jessica Paulsen
Associate Director for Digital Health in the Office of Product Evaluation and Quality (OPEQ)
Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA)
Sonja Fulmer
Deputy Director for the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH)
FDA

FDA 101

Stage 01
September 21, 2023 | 03:15 PM (PST) - 04:15 PM (PST)

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 an overview of the regulatory perspective and a discussion about various Digital Health topics, including artificial intelligence/machine learning, cybersecurity, use of digital health technologies in clinical trials, and relevant policies.