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Mc Guire Woods
mcguirewoods. com > client-resources > alerts > 2026 > 7 > a-pathway-for-clinical-ai-developers-opens-fda-clears-first-software-as-a-medical-device-with-patient-facing-llm

A Pathway for Clinical AI Developers Opens: FDA Clears First Software as a Medical Device With Patient-Facing LLM

5+ hour, 30+ min ago  (692+ words) Mc Guire Woods - FDA Pathway Established " Up Doc's clearance demonstrates a viable regulatory pathway for Sa MD products incorporating patient-facing LLMs, though future approvals will depend on each product's intended functions, safety and efficacy. - Human Oversight Remains Critical " Clinical AI…...

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