Technical Writing and Regulatory Documentation

The contract seeks a subcontractor to produce technical reports and regulatory documentation that summarize simulation results and the performance of AI models for submission to the FDA. The work is critical for supporting regulatory compliance and must accurately convey complex technical data in a format that meets FDA standards, ensuring all findings are clearly documented, traceable, and aligned with applicable guidelines. The deliverables will serve as foundational materials in the agency’s evaluation process for AI-driven medical technologies. The opportunity is classified under NAICS code 541690 for other scientific and technical consulting services and is issued by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services. It is open as a subcontract with no set-aside designation, and responses are due by August 7, 2026. The place of performance and point of contact details are unspecified, but the work is expected to be completed remotely or as otherwise arranged, with the final documentation tailored to FDA requirements. Potential bidders must demonstrate expertise in technical writing for regulatory submissions and experience with AI model evaluation frameworks.