Regulatory Strategy and FDA Submission Support

The contract seeks comprehensive support for regulatory documentation and submissions to secure FDA approval or clearance for a dermal substitute, covering all critical pathways including Investigational Device Exemption IDE, 510(k) premarket notification, and Premarket Approval PMA. The work involves developing strategic regulatory plans, preparing technical and clinical documentation, coordinating with FDA reviewers, and ensuring compliance with all applicable federal requirements throughout the submission lifecycle. The contractor will be responsible for delivering timely, accurate, and scientifically robust submissions that align with current regulatory expectations and facilitate timely decision-making by the agency. This subcontract is issued under the authority of the Assistant Secretary for Preparedness and Response, part of the Department of Health and Human Services, with a North American Industry Classification System code of 541611 for management, scientific, and technical consulting services. The opportunity was posted on July 28, 2026, and responses are due by August 28, 2026. Performance is expected to be conducted from a location with a zip code of 77416, though no specific city or state is designated. The contract does not specify any set-aside status, and no point of contact information is provided publicly, with the full details accessible via the SAM.gov link.