FDA Discussion Paper: Considerations for the Regulation of Generative AI-Enabled Medical Devices

AMIA responded to FDA’s discussion paper on generative AI-enabled medical devices, recommending clearer boundaries between regulated device functions and non-device software. The comments propose a risk framework centered on the probability and severity of harm, adjusted by contextual factors such as human oversight, autonomy, evidence traceability, equity, and deployment scale. AMIA also calls for proportionate premarket evaluation, interoperable exposure and provenance tracking, continuous postmarket monitoring, and flexible change-control pathways that preserve safety, transparency, and accountability over time.