FDA Seeks Public Input on Regulating Generative AI Medical Devices
The U.S. Food and Drug Administration (FDA) has initiated a public consultation to address the regulatory oversight of medical devices powered by generative artificial intelligence (GenAI). The agency is accepting comments until October 19, 2026, as it explores new approaches for risk assessment, premarket review, and post-market monitoring of AI-enabled products. While the FDA has already authorized over 1,000 AI-enabled medical devices, most utilize conventional AI models. Generative AI systems, capable of producing novel text, images, or recommendations, introduce unique risks that current regulatory frameworks may not fully cover. Unlike traditional medical software that operates within predictable boundaries, GenAI can accept open-ended prompts, perform multiple subtasks, and generate variable responses, even with similar inputs. These systems often rely on large foundation models developed by third parties, adding complexity to transparency, validation, and accountability. The FDA's discussion paper ... 
