*Premarket AI screening tool for Data Integrity

Building on foundational development work initiated by the Medical Data Enterprise (MDE) group, this proposal requests contractor resources in FY27 to advance an artificial intelligence (AI)-based screening tool for data integrity (DI) review of incoming premarket submissions. The tool will automate detection of patterns indicative of duplicated data (including raw data, images, and test reports), forged or manipulated data, and other data integrity anomalies across submission types. Automated DI screening will reduce reliance on manual review, preserving reviewer time and increasing efficiency throughout the premarket review lifecycle. This initiative directly supports Agency and Center priorities by promoting responsible AI adoption in regulatory review, driving innovation and speed to market, and strengthening accountability for submitters - with particular emphasis on those relying on foreign testing laboratories. Contractor engagement will ensure continuity with prior development efforts while providing the specialized technical capacity needed to bring the tool to a production-ready state.

Estimated value

>= $1.5M and < $3M

Est. solicitation date

Jul 1, 2026

Anticipated award

Jan 1, 2027