This Government Contract opportunity from Department Of Defense was posted on May 31, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
FDA Regulatory Compliance and Labeling
Contract Overview
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This subcontract focuses on ensuring that all components of medical kits comply with FDA requirements, including proper labeling, registration, and 510(k) clearance. The contractor is responsible for supporting the submission process for regulatory approvals and maintaining all necessary compliance documentation to meet federal standards. The contract is tied to the medical supply chain and managed by the Department of Defense, specifically under the MEDICAL SUPPLY CHAIN MD SURG FSF. The work will be performed in Annville, with a response deadline set for early June 2026. The scope of the contract revolves around regulatory compliance, emphasizing adherence to FDA guidelines to facilitate smooth product approval and ongoing regulatory maintenance. The NAICS code assigned to this opportunity is 541611, which corresponds to administrative management and general management consulting services, highlighting the compliance support role rather than product manufacturing or direct supply.
General Info
Agency
NAICS
Place of Performance
ANNVILLE, PA, 17003-5003, USASet-Aside
Documents
This scope was carved out of SPE2DS-26-T-109D.
The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.
RESUSCITATION KIT, M
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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