Medical Device & Software AI Regulation is part of the
Sunnybrook Medventions Lecture Series
This Lecture will be held on Zoom on February 16th from 2:00pm-4:00pm PST (5:00pm-7:00pm EST), featuring guest speaker Dr. Jayson Parker.
Artificial intelligence has exploded on the consumer landscape. Impact on medical device design grows each year. FDA regulation of software is evolving at a fast pace. We will briefly review some key aspects of medical device and software regulation. The state of the art for current AI regulation will be summarized. Our focus is on the next phase the FDA has yet to formulate: how to regulate AI that is allowed to learn in real time once released on the market. Inflection points in new product submissions to drive us forward will be highlighted.