This Government Contract opportunity from Department Of Defense was posted on May 15, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Clinical Validation & Regulatory Strategy
Contract Overview
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AI Contract Overview
This contract involves conducting clinical and analytical validation studies using real-world human specimens. The primary objective is to develop a regulatory pathway for FDA submission, with a focus on establishing eligibility for a CLIA waiver. It is structured as a subcontract under NAICS code 541690 and is sponsored by the Department of Defense, specifically through the W6QK Acc-apg agency. The work will be performed in Frederick, with a submission response deadline set for May 22, 2026. The contract aims to bridge scientific validation with regulatory strategy, ensuring that the clinical data supports FDA approval and facilitates streamlined laboratory use under CLIA guidelines. This comprehensive approach is critical for advancing medical diagnostics or related technologies toward market readiness under federal oversight.
General Info
Agency
NAICS
Place of Performance
Frederick, MD, USASet-Aside
Documents
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Timeline
Submission Closed
