Regulatory Strategy and FDA Submission Support

This contract involves providing specialized regulatory consulting and support services for FDA Center for Devices and Radiological Health (CDRH) submissions related to neuromodulation devices. The scope includes assistance with 510(k) and De Novo regulatory pathways, as well as the preparation and review of design control documentation essential for compliance with FDA requirements. The contract is categorized under NAICS code 541611, indicating management consulting services. Issued by the Advanced Research Projects Agency for Health (ARPA-H), under the Department of Health and Human Services, the opportunity is a subcontract arrangement. The solicitation was posted on June 16, 2026, with responses due by August 12, 2026. While specific geographic details for performance and organizational types are not provided, the contract emphasizes critical support to facilitate FDA approval processes for innovative neuromodulation technologies, underscoring the importance of regulatory expertise in medical device development within a government research framework.