Regulatory Science and Validation Framework Development

The contract seeks the development of design validation frameworks specifically tailored to ensure AI-accelerated models satisfy FDA regulatory requirements for reproducibility, traceability, and overall acceptance within clinical and regulatory environments. The work involves creating structured methodologies and validation protocols that align with current and evolving FDA guidance, ensuring that AI-driven tools used in healthcare decision-making meet rigorous standards for reliability, transparency, and audibility. This effort is critical to bridging the gap between advanced computational models and the stringent documentation and validation expectations of medical device and digital health product approvals. The contract is issued as a subcontract under NAICS code 541690, indicating it falls under other scientific and technical consulting services. It is sponsored by the FDA Office of Acquisition and Grant Services within the Department of Health and Human Services, with a response deadline set for August 7, 2026. The work must be performed to support federal regulatory objectives, though the specific place of performance and point of contact are not disclosed. Entities interested in responding must do so before the deadline to contribute to the advancement of regulatory science in artificial intelligence applications within the healthcare sector.