Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft
The FDA Law Blog
FEBRUARY 13, 2025
The update procedures should include how the AI-DSF modifications will be implemented and communicated to end users. Additionally, a failure is NOT considered unresolvable if a root cause analysis of the failure reveals it is not related to specific aspects of the PCCP. In such cases, performance testing may be conducted again.
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