FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products JD Supra

The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The Result: Both the 21st Century Cures Act and recent FDA activities provide important, but incomplete, insight regarding regulation of health products utilizing artificial intelligence. Looking Ahead: Digital health product manufacturers should recognize how recent regulatory changes may affect them, and that FDA is engaging industry to further refine its oversight approach. Artificial intelligence ("AI") can be broadly defined as a device or product that can imitate intelligent behavior.