FIRF RECOMPETE TO: #11: Premarket/Postmarket Services

This contract is a forecast for the FIRF Recompete Task Order 11 regarding Premarket and Postmarket Services for the Food and Drug Administration. The primary objective is to secure contractor services to support the CDRH Registration and Listing Program, which assists approximately 31,000 medical device establishments annually. The selected contractor will manage the CDRH Registration and Listing Helpdesk, providing guidance on registration requirements and helping firms submit electronic information through the FDA Unified Registration and Listing System and the Device Registration and Listing Module. Key responsibilities include reviewing reports, executing routine queries, and managing data entry and corrections within FURLS, DRLM, and FACTS systems, as well as handling stakeholder correspondence. This opportunity is designated as a Total Small Business Set-Aside under NAICS code 561990. The program ensures that medical device establishments remain compliant with annual registration user fees and listing requirements.