Regulatory Compliance & FDA Coordination Services

The contract requires comprehensive regulatory support for medical devices supplied to the Defense Logistics Agency, with a primary focus on ensuring compliance with FDA regulations under 21 CFR. This includes preparing and submitting regulatory documentation to the FDA, managing EBS referrals, and completing necessary device registrations to maintain legal market access. The contractor must navigate the full lifecycle of regulatory requirements, from initial submission through ongoing compliance, ensuring all devices meet federal standards for safety, labeling, and reporting. The work is tied directly to the Department of Defense’s medical supply chain and must align with the stringent protocols governing military medical equipment. Performance is centered at Fort Bliss, Texas, with all regulatory activities conducted to support DLA’s acquisition and distribution functions. The subcontract is solicited under NAICS code 541611, indicating a focus on management consulting services within the regulatory domain. Proposals are due by July 30, 2026, and the effort is part of a broader initiative to secure continuous regulatory adherence across the defense medical supply network. Timely and accurate coordination with FDA processes is critical to avoid disruptions in the delivery of essential medical devices to U.S. military personnel.