Haynes and BooneยทFDA / LIFE SCIENCES REGULATORY

FDA issues discussion paper seeking input on GenAI-enabled devices

The FDA's Aug. 19 discussion paper proposes regulatory concepts for generative AI-enabled medical devices and invites industry comment, an early step rather than binding policy.

fdamedical-devicesgenerative-airegulatory-pathwaydiscussion-paperai-enabled-devices

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