Regulatory Compliance and FDA Coordination Services

This contract requires comprehensive support to meet U.S. Food and Drug Administration regulatory obligations for medical devices under 21 CFR 870.4450, specifically focusing on product listing, 510(k) verification, and coordination of FDA referrals tied to FMS delivery orders. The work demands precise adherence to federal medical device regulations, ensuring all necessary documentation and submissions are accurately prepared and submitted in a timely manner to maintain compliance and enable uninterrupted delivery of defense-related medical equipment. The contractor must possess expertise in FDA regulatory frameworks and be able to interface effectively with agency processes on behalf of the Defense Logistics Agency. The contract is structured as a subcontract under the Department of Defense, managed by the Defense Logistics Agency, with a NAICS code of 541611 indicating it falls under administrative management and general management consulting services. It was posted on July 17, 2026, and is linked to a specific delivery order identified by the contract number SPE2DS26P2514. While no specific location for performance is designated, the scope implies nationwide coordination with federal agencies and potentially international FMS partners, requiring robust systems for documentation management, regulatory tracking, and interagency communication to fulfill all compliance obligations without delay.