Regulatory and Compliance Support for FDA-Regulated Devices

The contract seeks regulatory consulting services to ensure full compliance with FDA, Department of Defense, and Federal Acquisition Regulation requirements specifically for labeling, material safety data sheets, and hazard communication related to FDA-regulated medical devices. The work is scoped to support the Medical Supply Chain MD Surg FSF under the Department of Defense, with performance centered at Offutt Air Force Base, ZIP 68113-1044. The solicitation is classified as a subcontract under NAICS code 541611 for administrative management and general management consulting services, with responses due by August 10, 2026, following a posting date of August 3, 2026. The contractor must possess expertise in navigating the overlapping regulatory frameworks of the FDA and DoD, ensuring that all product documentation, warnings, and hazardous material disclosures meet stringent federal standards for safety, traceability, and operational readiness in defense supply chains.