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Regulatory Considerations for Medical XR Across Multiple Specialties

TALK OVERVIEW This webinar talk will provide an overview of the regulatory process and the specific regulatory considerations and evaluation challenges for Medical XR across multiple specialties, including orthopedics, neurology, radiology, and ophthalmology. The session will provide an overview technical and clinical regulatory considerations for each specialty. Finally, the session will discuss the importance of training and adverse event reporting for the continued improvement of the applications using augmented and virtual reality. SPEAKERS Laurence Coyne Ph.D. Division Director, OHT6: Office of Orthopedic Devices, OPEQ, CDRH, FDA Chris Harner MD Clinical Deputy Office Director/OHT6: Office of Orthopedic Devices, FDA/CDRH Michel Janda Medical Device Lead Reviewer, FDA/PHS Lisa Kinnard Ph.D. General Engineer, FDA Alex Beylin Ph.D. Senior Lead Reviewer, FDA Ian Broverman MS Medical Device Reviewer, FDA MODERATOR Ryan Beams Ph.D. Physicist, OSEL/CDRH/FDA