FDA considers doctor-like ‘competency-based’ tests for medical generative AI
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ByChristian Robles,
Technology Reporter, Nextgov/FCW
August 20, 2026 12:42 PM ET
The Trump administration released ideas for regulating large language models used in health care as companies roll out chatbots to help patients manage mental health, diabetes and other medical conditions.
The Food and Drug Administration wants the public to weigh in on whether chatbots should pass “competency-based” tests — similar to exams doctors must take — before they are marketed as medical devices.
FDA’s medical device center “is considering a competency-based approach to premarket evaluation of GenAI-enabled devices that is also inspired, at a high level, by how human clinicians are evaluated and credentialed, but would be adapted for the technical, practical, and legal considerations applicable to the regulation of medical devices,“ according to a discussion draft the agency published Tuesday.
FDA would test the final, user-facing generative AI product rather than...
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