The evidence behind the guides

Sources

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TopicCollection

Sources for Model-lifecycle regulation in medicine

1 source

Guide citations are still under editorial review.

US Food and Drug Administration · August 2025 Final guidance

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (original source, new tab)

Recommendations for specified planned changes, methods and impact assessment. Not permission for unrestricted self-modification.

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