FDA Regulatory Compliance and Submission Support

This contract focuses on ensuring full compliance with FDA regulations specifically for Class I medical devices. It requires managing essential regulatory tasks such as device registration, proper labeling, and adherence to Good Manufacturing Practices (GMP). Additionally, the contract includes supporting the submission of necessary data to facilitate evaluation under the Defense Logistics Agency (DLA) procurement rules, thereby aligning regulatory compliance with government purchasing requirements. The opportunity is a subcontract associated with the Department of Defense’s Medical Supply Chain MD SURG FSF office with a performance location at APO, zip code 09227-0000. The contract falls under NAICS code 541611, which pertains to administrative management and general management consulting services. The solicitation was posted on May 31, 2026, with a response deadline of June 8, 2026. This contract plays a critical role in ensuring that medical devices procured meet both FDA regulatory standards and DLA evaluation criteria, supporting the integrity and safety of medical supplies in the defense sector.