FDA Device Chief Pitches Assurance Labs For AI Development

FDA device center chief Jeff Shuren said the agency is considering creating “assurance labs” for the development of artificial intelligence in medical devices where developers could have access to larger data sets and a “safe space” for design. A primary goal for FDA, Shuren said, is striking the right balance between pre-market certification and post-market surveillance of AI. “We are also looking at considerations for creating assurance labs -- having the ability of larger data sets, and if you will,...