ATA Action Responds to FDA on Generative AI Medical Devices: Two-Axis Risk, PCCPs ...

ATA Action submitted detailed feedback to the FDA endorsing a two-axis risk framework for regulating generative AI medical devices based on clinical function and risk, urging real-world risk standards that consider rural healthcare access. They also proposed a voluntary federal-state clinical AI regulatory sandbox to harmonize fragmented state rules with FDA standards and improve deployment in underserved areas.

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