*Radiological AI Adoption Support Contract
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 contract support to develop materials that facilitate adoption of safe and effective radiological artificial intelligence medical devices across US imaging facilities, with estimated solicitation release on 2026-07-01 and estimated award on 2027-01-01. The contract requires development of quick-start guides, templates, and supporting materials aligned with modern frameworks such as the American College of Radiology's ARCH-AI, with explicit focus on enabling smaller and remote imaging facilities to execute model selection, local acceptance testing, user training, AI governance, and device performance monitoring. The work addresses gaps in specialized expertise that currently disadvantage facilities where radiological AI deployment may benefit patients most, and will inform development of regulatory controls, postmarket monitoring, and real-world evidence collection for novel AI devices.
The estimated award value ranges from $1.5 million to $3 million, with the contract providing for multiple awardees and pilot studies at multiple sites. Supporting materials must enable integration with the Centers for Medicare and Medicaid Services' health technology ecosystem to support data exchange, reimbursement alignment, and incorporation of AI-generated insights into care delivery and quality measurement infrastructure. Inquiries should be directed to cdhracquisitions@fda.hhs.gov.
Forecast text
This is a significant expansion of an earlier FY27 budget request to fund the development of supporting materials to aid and encourage adoption of safe and effective radiological AI medical devices across a broad range of current facility capabilities.Safe and effective deployment of radiological AI at imaging facilities currently relies on specialized expertise to evaluate model selection, perform local acceptance testing, train users, employ appropriate AI governance, and monitor device performance. Smaller imaging facilities and those in remote locations in the US often lack the resources to execute these functions, putting facilities where AI that may benefit patients the most at a disadvantage for deploying modern radiological AI software. Furthermore, expanded adoption and standardization of these practices and modern technologies at imaging facilities will inform the development of special controls for novel AI devices, tailored postmarket monitoring infrastructure, and collection of real-world evidence for device evaluation and quality measurement. This request is for a contract to develop quick-start guides, templates, or other supporting materials to aid and encourage adoption of safe and effective radiological AI medical devices and real-world data collection according to modern frameworks such as the American College of Radiology's ARCH-AI.This expanded request would provide for the option of multiple awardees, fund pilot studies at multiple sites, and explicitly call for materials to support integration with the Centers for Medicare and Medicaid Services' health technology ecosystem, enabling seamless data exchange, supporting reimbursement alignment, and ensuring that AI-generated insights can be integrated into broader care delivery and quality measurement infrastructure.
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