CDR Brad Cunningham is a biomedical engineer at the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH). He spent many years as an engineering reviewer and team leader for intraocular lenses, and corneal and glaucoma implants. In 2009 he was selected as the branch chief of the Diagnostic and Surgical Devices Branch, where supervised the premarket review and approval of ophthalmic surgical devices, refractive lasers, retinal implants, and optical and laser imaging devices. He held this role until 2019 when we has then selected as the Associate Director for the Office of Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices. In this current role, he oversees pre- and post-market review activities across the office, serving as a senior advisor for high-profile review matters and as a subject matter expert for digital health (software as a medical device, artificial intelligence, machine learning). Throughout his 18 years at FDA, he held collateral duty positions, such as the engineering technical expert ANSI standards committees and interim director for the Division of Patient Safety Partnerships. In recent years, he has taken an active leadership role in the development of new policies and regulations around digital health technologies, including devices that incorporate adaptive algorithms and artificial intelligence functionality for use in critical and non-critical medical applications. CDR Cunningham received his undergraduate and graduate degrees in bioengineering from the University of Maryland, College Park and continues to serve as adjunct faculty for engineering design courses. As an active officer of the Commissioned Corps of the U.S. Public Health Service, he has served as a leader in the Engineering Professional Advisory Committee as well as on PHS-1 Rapid Deployment Force as the team’s Training Coordinator.