Artificial Intelligence-Enabled Device 1 Software Functions: Lifecycle 2 Management and Marketing 3 Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff

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.