FDA Regulatory Compliance and Labeling

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.