The AI/ML FDA Plan

“The ability for AI/ML software to learn from real-world feedback (training) and improve its performance (adaptation) makes these technologies uniquely situated among SaMD and a rapidly expanding area of research and development. Our vision is that with appropriately tailored regulatory oversight, AI/ML-based SaMD will deliver safe and effective software functionality that improves the quality of care that patients receive. “

The “Proposed Framework”?


Pilot: AI-guided Cardiac Ultrasound

Digital Health Center of Excellence

The Action Plan

A last-minute hurdle?



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