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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

Closed
Federal

Contract Overview

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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

Conduct clinical validation using human specimens for FDA submission and CLIA waiver, DOD-sponsored, deadline May 2026.

Agency

Department Of Defense → W6QK Acc-apg

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

Frederick, MD, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Defense → W6QK Acc-apg
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Defense → W6QK Acc-apg
Office AddressN/A
ContactsNo contact information available

Full Description

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Conduct clinical and analytical validation using real-world human specimens and develop a regulatory pathway for FDA submission including CLIA waiver eligibility strategy.