Regulatory Strategy & FDA Submission Support

This contract involves the development and execution of a comprehensive regulatory strategy focused on obtaining FDA clearance or approval for both diagnostic and therapeutic components. The scope includes preparing submissions such as 510(k), De Novo, or Premarket Approval (PMA) applications, ensuring compliance with regulatory requirements to facilitate product market entry. The contract is categorized as a subcontract under NAICS code 541611 and is managed by the Advanced Research Projects Agency for Health (ARPA-H) within the Department of Health and Human Services. The opportunity was posted on June 16, 2026, with a response deadline of July 10, 2026. While specific details about the place of performance and point of contact are not provided, the task centers on strategic regulatory support, essential for guiding innovative health technologies through the complex FDA approval process. This contract is critical for advancing novel medical diagnostics and therapeutics by navigating regulatory pathways efficiently and effectively.