Comment from George Evgrafov
AnonymousSupportIndividual
Summary: The commenter suggests that the FDA provide more specific guidance on life cycle maintenance and change control for AI models in drug development. They recommend incorporating elements like a model maintenance plan and adapting the Predetermined Change Control Plan (PCCP) framework from device regulation.
Life Cycle Maintenance and Change Control
The draft acknowledges that AI models may change over time (e.g., via retraining), but does not sufficiently define how life cycle maintenance should be handled in regulated settings.
Recommendation: I recommend that FDA clarify expectations regarding ongoing model performance monitoring, predefined acceptance criteria, and triggers for re-validation. Sponsors should be encouraged to document:
•A model maintenance plan
•Change control procedures for retraining
•Performance monitoring routines
The concept of a Predetermined Change Control Plan (PCCP), as seen in device regulation, could be adapted to support consistency and predictability in updates of AI models used in drug development.