Quantitative Decision Reliability of AI-Accelerated Computational Modeling and Simulation for Cardiovascular Devices

The Food and Drug Administration Office of Acquisition and Grant Services seeks responses to an amendment to RFQ133983 addressing computational fluid dynamics (CFD) modeling with surrogate modeling and decision reliability analysis for cardiovascular devices, with responses due August 7, 2026 by 10:00 a.m. EST.

The procurement carries no set-aside. NAICS code 541715 applies (Research and Development in the Physical, Engineering, and Life Sciences). The Government has clarified that the erroneous HL7 Reference Information Model requirement and Management Plan evaluation factor should be disregarded. Key Personnel will be evaluated against the Contractor Qualifications section of the Statement of Work, which requires demonstration of cardiovascular CFD expertise, peer-reviewed publications, regulatory-science experience, and surrogate-modeling expertise.

Contractor responsibilities include literature review, parameter-space sampling, simulation dataset generation, surrogate model delivery, and decision-reliability notebook development. CFD-versus-experimental validation comparisons fall outside the contract's purely computational scope unless a benchmark problem with existing experimental data (such as the FDA nozzle benchmark) is used, in which case comparisons are within Task 3. Offerors select the quantity of interest, decision threshold, and parameter space dimensionality. Pricing must be submitted as a single total project cost with payment due upon completion; milestone-based payments are not required. No formatting requirements apply and PDF submissions are acceptable for both technical and price sections. FAR 52.212-3 representations are required; UEI numbers are acceptable in place of DUNS numbers. Service Contract Labor Standards do not apply and there are no option periods under this acquisition.