Comment from Shiau Ru (ZuZu) Yang
AnonymousSupportAcademic
Summary: A senior researcher at National Cheng Kung University argues that the FDA should explicitly distinguish between measurement claims and clinical-utility claims for quantitative AI-enabled device software functions. The commenter suggests that because measurement validity often matures before clinical utility, the guidance should include specific lifecycle safeguards and labeling requirements to ensure these measurements are not misinterpreted as mature clinical decisions.
I am submitting the attached public comment regarding FDA Docket No. FDA-2024-D-4488, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.”
The comment recommends that FDA explicitly distinguish measurement claims from clinical-utility claims for quantitative AI-enabled device software functions, particularly where measurement validity may mature before clinical utility. It also recommends that the final guidance include a focused cross-cutting consideration and related lifecycle safeguards for such AI-DSFs.
The attached comment contains no confidential information.