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*Radiological AI Adoption Support Contract

Forecast

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The Food and Drug Administration is seeking a contract to develop supporting materials, such as quick-start guides and templates, to facilitate the safe and effective adoption of radiological AI medical devices. This initiative specifically targets smaller and remote imaging facilities that lack the specialized expertise required for model selection, local acceptance testing, and AI governance. By standardizing these practices according to frameworks like the American College of Radiology's ARCH-AI, the project aims to reduce disparities in patient care and provide critical real-world evidence to inform future special controls and postmarket monitoring for AI devices. This expanded effort allows for multiple awardees and the funding of pilot studies across various sites. A key objective is the integration of these tools with the Centers for Medicare and Medicaid Services' health technology ecosystem to ensure seamless data exchange and alignment with reimbursement structures. Ultimately, the contract seeks to embed AI-generated insights into broader care delivery and quality measurement infrastructure to improve the overall deployment of medical AI across diverse facility capabilities.

General Info

FDA seeks materials to help small facilities safely adopt radiological AI medical devices.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541618 - Other Management Consulting Services

Place of Performance

USA

Set-Aside

NONE

Documents

No documents available

Documents will appear here when they are available.

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cdrh Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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.