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Medical Device Regulation Primer: Focus on Digital Health

Thursday, October 12, 2017 5:00 p.m. - 8:30 p.m.

Location: Sunnybrook Health Sciences Centre, Lecture Theatre M6-502

Speaker: Dr. Jayson Parker, Associate Professor, University of Toronto, Mississauga.

Abstract: In this workshop, we will review and anticipate changes in medical device regulation, with special emphasis on digital health regulation. We will spend time on basics behind US Food and Drug Administration thinking in how medical devices are regulated, and by extension, how this applies to health-related apps, software and wearable technology. We will review the state of the art of FDA thinking. However, with the turbulent changes in the US environment, dramatic changes are expected at the FDA that could unhinge many current practices for product review. To help prepare the audience for this new impending world, we will look at the cornerstone logic of how products are regulated and how this can be applied differently. Best in class examples of new approaches to medical device regulation will also be highlighted, that the lecturer believes may anticipate forthcoming changes to the FDA.

Registration available online