Medical Device Manufacturing – Intraosseous Infusion System

The contract solicits the manufacture of Class II FDA-regulated intraosseous infusion systems designed for emergency vascular access, encompassing critical components such as the infusion tube, bone portal tip, luer connector, introducer, strain-relief patch, and protector dome. These devices must comply with stringent quality control and regulatory standards required by the FDA for Class II medical devices, ensuring safety, sterility, and performance under high-stress clinical conditions. The production must adhere to rigorous manufacturing protocols aligned with medical device quality systems and be capable of consistent scalability to meet operational demands. The solicitation is issued as a subcontract under the Department of Defense’s Medical Supply Chain, with performance designated at Fort Bragg, North Carolina, and a response deadline of July 29, 2026. The NAICS code 325620 indicates this is a pharmaceutical and medicine manufacturing activity, emphasizing the specialized nature of the product. The procurement is not subject to any small business set-aside designation, and all bidders are expected to demonstrate proven capability in producing FDA-cleared medical devices with documented compliance histories. The contracting office, part of the broader military logistics infrastructure, requires seamless integration of the final product into existing emergency medical supply chains used in operational and field environments.