The rapid development of consumer-grade augmented- (AR) and virtual-reality (VR) devices has created interest in leveraging these technologies across a wide range of medical applications including rehabilitation, image-guided surgery, and diagnostics. This presentation will include two parts: regulatory process and regulatory science efforts in AR/VR. The first part of the talk will provide an overview of how medical devices are evaluated for benefits and risks and special considerations relevant to AR/VR devices. The second part of the talk will focus on current regulatory science efforts to address the evaluation gaps in evaluating AR/VR device performance.
Peter J. Yang, Ph.D., RAC
De Novo Program Lead, Team Lead, FDA/CDRH/OPEQ/ORP/DRP1/TRP1A