The Guardrails
FDA floats doctor-style licensing exams for generative AI medical devices
The FDA is weighing whether generative AI health products should pass "competency-based" exams — modeled on how human clinicians are trained, tested, and credentialed — before they can be marketed as medical devices. The idea sits in a discussion draft the agency's device center published this week, and it is explicitly a question, not a rule: the FDA says the paper is "for discussion purposes only," with public comments open until October 19. The proposed framework would test the final, user-f
