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
Impact Assessment The Impact Assessment documents the benefits and risks of implementing the AI-DSF and the mitigations for the identified risks. The guidance states that the Impact Assessment can be a stand-alone document, incorporated into the manufacturers Risk Assessment, or included in the Modification Protocol.
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