Division Director, Digital Health Policy, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH)
FDA (Virtual)
Dr. MiRa Jacobs is the Division Director for the Division of Digital Health Policy, which is part of the Digital Health Center of Excellence at the FDA. She has worked at the Agency since 2018, first as Lead Reviewer in the Office of Product Evaluation and Quality, where she provided support for software and cybersecurity review in addition to her work as a lead reviewer on the neurointerventional devices team. She joined the Digital Health Center of Excellence in 2020 and has since contributed to numerous programs and initiatives with a focus on developing and implementing policy for AI-enabled medical devices, the maturation of Predetermined Change Control Plans, and international harmonization on approaches to Software and AI-enabled devices. Prior to joining the FDA, Dr. Jacobs earned her Ph.D. in biomedical engineering from the University of Florida.
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Thursday, November 13, 2025
1:40 PM - 2:25 PM East Coast USA Time