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

Estimated value

>= $1.5M and < $3M

Est. solicitation date

Feb 1, 2027

Anticipated award

Aug 1, 2027