Regulatory Strategy & FDA Submission Support

The contract entails the development and execution of a comprehensive regulatory roadmap to obtain FDA clearance or approval for a cyanide detection device intended for use as a medical diagnostic product. This includes designing a strategic pathway through the FDA’s premarket review process, which may involve determining the appropriate classification, preparing submission documentation such as a 510(k) or De Novo request, and aligning clinical and technical data to meet regulatory requirements. The effort requires deep expertise in medical device regulations, interaction with FDA reviewers, and coordination of validation studies and quality system compliance to ensure the device meets safety and efficacy standards. The project is structured as a subcontract under the Department of Homeland Security’s Science and Technology Acquisition Division, with a focus on advancing a diagnostic tool critical for public health and emergency response scenarios. The opportunity was posted on August 3, 2026, with a deadline for responses set for September 2, 2026. The NAICS code 541611 indicates the work falls under management, scientific, and technical consulting services, emphasizing the need for specialized regulatory strategy expertise rather than manufacturing or direct product development. Performance location details are unspecified, suggesting flexibility in execution as long as deliverables meet federal compliance standards and timelines.