FDA Regulatory Compliance & Submission Support

The contract seeks regulatory consulting services to ensure ongoing FDA compliance for Class II medical devices, with a focus on supporting 510(k) premarket notifications, facility registration, and quality system audits. The scope requires expert guidance to navigate FDA requirements and maintain adherence to regulatory standards throughout the device lifecycle, ensuring timely submissions and audit readiness. The work is critical for sustaining market access and operational compliance for medical products under the Department of Defense’s Medical Supply Chain. The subcontract is issued under NAICS code 541611 for administrative management and general management consulting services, with a performance location in Fort Hood, Texas at ZIP code 76544. It was posted on July 19, 2026, and responses are due by July 27, 2026. The contracting authority is the Department of Defense through its Medical Supply Chain MD SURG FSF office, and the solicitation number is SPE2DS26T247F, accessible via the DIBBS portal. All deliverables must align with FDA regulations and support the defense medical supply chain’s obligation to provide compliant, safe, and effective medical devices.