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Dr. Sonja Fulmer, PhD, is Assistant Director for Digital Health Policy in the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). In this role, Dr. Fulmer works to help advance and implement new policy approaches to medical device software and digital health technologies to better promote and protect public health. Dr. Fulmer has held several policy-focused positions in the Office of the Center Director and later as a Policy Advisor in the Office of Policy at CDRH. She has served as a policy expert for digital health topics since the passage of the 21st Century Cures Act in 2016 and has led the development of several software guidances that provide FDA’s interpretation of the software provisions of the Cures Act. Dr. Fulmer has overseen the development, publication, and implementation of many digital health policies, including the following guidances: Clinical Decision Support Software; Multiple Function Device Products; Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act; Policy for Device Software Functions and Mobile Medical Applications; General Wellness: Policy for Low Risk Devices; Off-The-Shelf Software Use in Medical Devices; Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; and the draft guidance Content of Premarket Submissions for Device Software Functions.