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