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SRC-4f6ff93d73646253 · Source record

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff

U.S. Food and Drug Administration · 1 connected claims

D04 · Health, Evidence, Supplements & Peptides D09 · Legal, Compliance, Trust & RegTech D18 · Operations, Governance & Organization

Canonical route

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

Claims connected to this source

MWITA-CR-2026-0008Metatron sollte Health-Aussagen als versionierte, juristiktions- und populationsgebundene Claims führen und AI auf Suche, Extraktion und Widerspruchserkennung begrenzen, während medizinische Schlussfolgerung und Freigabe unter fachlicher menschlicher Autorität bleiben.Evidence B

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