Digital Health Benchmarking, Clinical Confirmation and Lifecyle Validation
Forecast New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $1,500,000 to $3,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CDRH Acquisition Liaison cdhracquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring services to build end-to-end capability for digital health medical device evaluation across premarket review, evaluation science, and postmarket oversight, with solicitation estimated for release on February 1, 2027, and award targeted for August 1, 2027. The program will 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.
The estimated award value ranges from $1.5 million to $3 million. Inquiries should be directed to the FDA's Center for Devices and Radiological Health Acquisitions mailbox at cdhracquisitions@fda.hhs.gov.
Forecast text
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
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