Digital Health Center of Excellence

The U.S. Food and Drug Administration (FDA) is developing a plan to regulate medical devices that use generative artificial intelligence, according to Rick Abramson, director of the agency's Digital H…

The U.S. Food and Drug Administration (FDA) is developing formal policy guidance for regulating medical devices that use generative artificial intelligence, according to Rick Abramson, director of the…

The U.S. Food and Drug Administration (FDA) released a discussion paper on August 18, 2026, outlining potential regulatory approaches for generative AI-enabled medical devices, with comments due Octob…