This Government Contract opportunity from Department Of Defense was posted on July 26, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
FDA Regulatory Compliance Consulting
Contract Overview
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The contract seeks consulting services to ensure full compliance with FDA regulations under 21 CFR Part 820 for Class II medical devices, with a focus on labeling accuracy and audit preparedness. The work will support the Department of Defense’s Medical Supply Chain through a subcontract arrangement, requiring the contractor to implement and maintain quality systems that meet federal medical device standards, specifically addressing documentation, process controls, and regulatory documentation needed to pass FDA inspections. Performance is expected to occur at Fort Bragg, North Carolina, with a response deadline of August 3, 2026, and the solicitation is classified under NAICS code 541611 for management, scientific, and technical consulting services. The contract aims to strengthen regulatory readiness for medical devices used in military healthcare settings, emphasizing ongoing compliance and operational alignment with evolving FDA expectations.
General Info
Agency
NAICS
Place of Performance
FORT BRAGG, NC, 28310, USASet-Aside
Documents
This scope was carved out of SPE2DS-26-T-268X.
The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.
NEEDLE, ACUPUNCTURE
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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