AHA details recommendations to FDA on regulatory frameworks for GenAI-enabled medical devices 

The AHA provided recommendations to the Food and Drug Administration Oct. 19 on potential regulatory frameworks for generative artificial intelligence-enabled medical devices. The AHA expressed support for a flexible, risk-based regulatory framework that protects patients without impeding responsible innovation. Among its suggestions, the AHA recommended the FDA refine the proposed risk heuristic for evaluating the risk of GenAI applications and provide labelling guidance on “informational action directing” devices versus “action taking” devices. The AHA also requested the agency to align premarket clearance and post-deployment evaluation and monitoring activities under a total product lifecycle and clarify that GenAI-enabled clinical decision support and administrative tools are not subject to FDA oversight.