Digital Health Benchmarking, Clinical Confirmation and Lifecyle Validation

Build FDA's end-to-end capability for new and innovative digital health medical devices across (1) premarket review, (2) evaluation science, and (3) postmarket oversight. The program would develop clinically grounded failure-mode taxonomies, benchmark design principles, evaluation protocols, reusable test sets or specifications where feasible, methods for weighting clinically consequential errors, approaches for subgroup and use-context analysis, and frameworks for assessing digital health confirmation and post-update performance.