Comment from George Evgrafov
AnonymousSupportIndividual
Summary: The commenter suggests that the FDA clarify the scope of the guidance to include AI systems used to generate or transform data submitted to the Agency, even if their primary purpose is operational. They argue this will improve alignment and prevent misclassification of AI systems.
Clarify Scope of “Supporting Regulatory Decision-Making”
The current draft distinguishes between AI used for operational efficiency and that used for regulatory decision-making, but this boundary is often unclear.
Recommendation: I encourage the FDA to clarify that AI models or systems used to generate or transform data that is ultimately submitted to the Agency—even if the model’s primary purpose is operational—should be considered within scope. Conversely, AI systems that are entirely unrelated to data entering regulatory pathways may remain outside the scope. This clarification will improve alignment and help avoid misclassification.