*Constructing a Continuous, Registry-independent, AI-enhanced RWE Infrastructure
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $7,000,000 to $13,000,000
- 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 construct a continuous, registry-independent, AI-enhanced real-world evidence infrastructure for medical device post-market surveillance, with solicitation estimated for release on July 1, 2026, and award anticipated on January 1, 2027. The infrastructure will draw directly from electronic health records and primary clinical data sources to overcome limitations inherent in existing registry and administrative claims data approaches, supporting longitudinal, lifelong surveillance with prospectively pre-specified parameters and capacity for federated or aggregated architectures.
The estimated award value ranges from $7 million to $13 million. Inquiries should be directed to the FDA's Center for Devices and Radiological Health Acquisitions mailbox at cdhracquisitions@fda.hhs.gov.
Forecast text
Post-market surveillance is a core FDA mandate to ensure the continued safety and effectiveness of medical devices throughout their total product life cycle. Device-specific post-approval studies often have a limited reach both horizontally and longitudinally. Registries, administrative claims data, and the linkages between them have provided invaluable real-world data for post-market surveillance. However, registries and claims data also have limitations. For example, national registries often have decreasing data completeness over time, and CMS claims data lack granularity and do not include non-Medicare beneficiaries.The proposed project aims to overcome some of the limitations of the registry/claims-based post-market surveillance paradigm by drawing directly from the primary sources of real-world clinical data (electronic health records, EHRs) and to construct a continuous, registry-independent, AI-enhanced real-world evidence (RWE) infrastructure for medical device surveillance. This infrastructure has the following core characteristics:Registry-independentAI-nativeCould support a federated or aggregated architectureLongitudinal and lifelongProspectively pre-specified
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