Foley & Lardner LLP Partner Kyle Faget is quoted in the Stat+ article, “The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight,” discussing the increased scrutiny the U.S. Food and Drug Administration’s (FDA) is putting upon artificial intelligence-powered clinical decision support (CDS) tools as devices.
Faget said, “[the FDA’s final CDS guidance released in September 2022] was a pretty big pivot from the draft guidance. Part of me was surprised when the FDA took such an arguably aggressive stance.”
Faget noted the FDA’s concern of automation bias in regulating these digital health tools. “If I walk into the emergency room and I give a list of my symptoms, and the output is going to be what the clinician uses to diagnose and treat me, then yeah, I kind of want FDA looking at that and making sure that whatever our algorithm is being relied upon is actually a validated algorithm,” she said.
While it’s unclear how FDA will target companies not in compliance, Faget added that the agency will only likely need to loudly enforce a few major players for the rest to fall into line.