FDA Regulatory Compliance and Submission Support

The contract entails providing FDA referral documentation and regulatory compliance support for the export of medical devices under the Federal Medical Service program, ensuring full adherence to 21 CFR regulations and Defense Logistics Agency requirements. This work involves preparing and submitting the necessary regulatory materials to facilitate the lawful international shipment of medical devices, with a focus on maintaining compliance with U.S. food and drug administration standards and DLA operational protocols. The subcontract is classified under NAICS code 541611, indicating professional, scientific, and technical services related to administrative management and regulatory compliance. It is issued by the Department of Defense through the Defense Logistics Agency, with the performance location unspecified and no set-aside status designated. The contract was posted on July 14, 2026, and is accessible via the DIBBS system under contract number SPE2DS26P2434. The scope is strictly regulatory, requiring expert knowledge of FDA submission processes and export control laws applicable to medical devices under federal contracts.