Foley partner Kyle Faget, co-chair of the firm’s Medical Devices Area of Focus, is speaking at the American Bar Association Health Law Section’s Healthcare Delivery & Innovation Conference on September 30.
Faget’s session will explore how the U.S. Food and Drug Administration (FDA) is regulating AI-enabled medical devices. The presentation will specifically address FDA’s recent guidance documents regarding lifecycle considerations and specific recommendations to support marketing submissions for devices utilizing AI. Additionally, marketing submission recommendations for a predetermined change control plan for AI-enabled medical device software functions will be explored. Participants will leave the talk understanding what steps FDA has taken recently to support innovation in this space.
CLE
The ABA will seek 11.75hours of CLE credit in 60-minute states, and 14.1 hours of CLE credit for this program in 50-minute states Credit hours are estimated and are subject to each state’s approval and credit rounding rules.
