Gottlieb: Congress Should Craft FDA Reg Paradigm For AI Similar To LDT Bill’s Approach

Former FDA Commissioner Scott Gottlieb says FDA should regulate AI-driven medical products using a “firm-based” approach under which the agency assesses an AI tool's reliability by evaluating the methods used in its development and closely overseeing the quality systems and processes of the manufacturing firm, but he says Congress would need step. Gottlieb suggests lawmakers borrow from the approach they used to write legislation that would create a new regulatory paradigm for laboratory developed tests. Experts say AI models are...