FDA seeks feedback on measuring AI-enabled medical device performance

The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial intelligence-enabled medical device performance in real-world applications. This includes approaches to detect, assess and mitigate performance changes over time to help assure the devices remain safe and effective throughout their life cycle. The FDA is accepting comments at www.regulations.gov until Dec. 1. The notice follows a request by the Office of Science and Technology Policy issued Sept. 26 that seeks feedback on federal regulations that hinder AI development, deployment or adoption.