FDA Regulatory and Labeling Compliance Support

The contract seeks regulatory consulting services to ensure full compliance with FDA requirements for medical device registration, listing, labeling, and good manufacturing practices, even though the products involved do not require a 510(k) premarket notification. The scope of work focuses on navigating FDA regulations to maintain proper documentation and operational adherence without the need for premarket clearance, emphasizing ongoing compliance across the product lifecycle. Services must align with federal standards while supporting the Department of Defense’s Medical Supply Chain team in delivering compliant medical devices. Performance will be conducted remotely with a place of performance listed as FPO, ZIP 96660, indicating a military postal address, and the work is classified as a subcontract under NAICS code 541611 for management, scientific, and technical consulting services. The solicitation was posted on August 3, 2026, with a response deadline of August 10, 2026, and is issued under the agency name Medical Supply Chain MD Surg FSF. All deliverables must meet exacting FDA compliance benchmarks without reliance on 510(k) pathways, requiring deep expertise in labeling accuracy, facility registration, and quality system controls under GMP.