FDA-Regulated Product Compliance and Submission Support

The contract seeks support for regulatory compliance services related to FDA-regulated medical devices, with a focus on submission preparation, device classification, and coordination with DLA product specialists to ensure adherence to federal standards. The scope includes navigating the complex regulatory landscape for medical devices under FDA oversight, requiring expertise in documentation, classification pathways, and interagency coordination to facilitate timely and compliant submissions. This subcontract is tied to the Department of Defense’s Medical Supply Chain MD Surg FSF and will be performed at Fort Bragg, North Carolina, with a zip code of 28310. The opportunity was posted on August 4, 2026, and responses are due by August 10, 2026, under NAICS code 541611, which corresponds to management consulting services, indicating the need for strategic regulatory advisory support rather than direct manufacturing or clinical services.