FDA Regulatory Strategy & IDE Submission Support

The contract seeks a contractor to lead the end-to-end preparation and submission of an Investigational Device Exemption (IDE) application to the FDA for a medical device under development. This includes developing a robust clinical protocol, coordinating with Institutional Review Boards (IRBs), executing investigator agreements, and compiling all necessary regulatory documentation to ensure full compliance with FDA requirements. The contractor must demonstrate expertise in navigating the complex regulatory landscape for investigational devices and ensure timely, accurate, and complete submission of the IDE package. The work is being conducted as a subcontract under the Defense Health Agency, part of the Department of Defense, with performance based in Frederick, Maryland, ZIP code 21702. The opportunity is open for bids until July 15, 2026, at 4:00 PM ET, and is classified under NAICS code 541611, which pertains to administrative management and general management consulting services. There is no set-aside designation, and the agency is seeking qualified firms capable of delivering high-level regulatory strategy and execution to support federal medical innovation efforts.