*Premarket AI screening tool for Data Integrity
Past 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 contractor resources to advance an artificial intelligence-based screening tool for data integrity review of premarket submissions, with an estimated solicitation release on July 1, 2026, and estimated award on January 1, 2027. The tool will automate detection of duplicated data (including raw data, images, and test reports), forged or manipulated data, and other data integrity anomalies across submission types, reducing reliance on manual review and increasing efficiency throughout the premarket review lifecycle. The initiative supports FDA priorities in responsible AI adoption, innovation, speed to market, and submitter accountability, with particular emphasis on submissions relying on foreign testing laboratories.
The estimated award value ranges from $1.5 million to $3 million. Contractor engagement will ensure continuity with prior development efforts conducted by the Medical Data Enterprise group while providing specialized technical capacity to bring the tool to production-ready state. Inquiries should be directed to cdhracquisitions@fda.hhs.gov.
Forecast text
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.
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