U.S. Food and Drug Administration (FDA)
Dr. MiRa Jacobs is the Division Director for the Division of Digital Health Policy at the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). Dr. Jacobs’s work is focused on the development of policies and regulatory approaches intended for safe and effective devices enabled by emerging digital health technologies. She supports a number of the DHCoE’s many ongoing initiatives, including developing new policy and regulatory approaches for the use of Artificial Intelligence (AI) in medical devices, the unique considerations of medical device software, as well as efforts to promote international harmonization in these areas to ensure patient safety and advance healthcare. Dr. Jacobs also leverages her experience as a Lead Reviewer and a software and cybersecurity consultant in the Office of Neurological and Physical Medicine Devices in the Office of Product Evaluation and Quality (OPEQ) to help further the diverse work of the DHCoE. Prior to joining the FDA, Dr. Jacobs earned her PhD in biomedical engineering from the University of Florida.
Accelerating Regulatory Discussion on Digital Health Devices
Thursday, October 9, 2025
3:15 PM - 4:15 PM EST