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Medical AI needs lifecycle evidence
FDA draft guidance frames safety and effectiveness across planning, development, testing, documentation, deployment and monitoring. Approval evidence is not a one-time snapshot for systems that may change.
U.S. Food and Drug Administration6 January 2025Reviewed 26 July 2026
FUURAA original conceptual visualWhat the evidence indicates
A concise reading of the source
FDA draft guidance frames safety and effectiveness across planning, development, testing, documentation, deployment and monitoring. Approval evidence is not a one-time snapshot for systems that may change.
FUURAA interpretation
Why this could matter
Developers should preserve traceable evidence from design decisions through real-world performance.
How to read this signal
Documented development
The underlying event, report or finding has been published. Its future consequences may still be uncertain.
