Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)

The Department of Health and Human Services, through the National Institutes of Health (NIH), has reissued a funding opportunity titled "Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)" under Funding Opportunity Number PAR-25-383. This initiative is backed by multiple NIH Institutes and Centers, including the National Institute of Neurological Disorders and Stroke (NINDS), the National Eye Institute (NEI), and the National Institute on Aging (NIA), among others. These institutions collaboratively support neuroscience research and are joined by the NIH’s BRAIN and HEAL Initiatives. The primary goal is to accelerate the translation of innovative medical devices that can prevent, monitor, diagnose, or treat disorders aligned with the missions of the participating organizations. The grant mechanism is structured as a phased cooperative agreement—UG3 followed by UH3. The UG3 phase supports preclinical activities such as prototype development, non-clinical safety testing, and regulatory submissions like IDE or IRB approvals. Projects that meet specific milestones in this phase may transition to the UH3 phase, which supports subsequent clinical studies. The total project period may not exceed five years. Applications should detail a two-phase plan and include milestone-driven objectives. Notably, award budgets are not capped but must be justified, and NIH will fund service providers directly rather than through applicant budgets. Eligible applicants include a wide range of entities: higher education institutions, nonprofits, for-profits including small businesses, and various government and tribal organizations. Foreign entities are also eligible, as are foreign components of U.S.-based institutions. All applicants must be registered with SAM, eRA Commons, and Grants.gov, and all principal investigators must hold an eRA Commons ID. No cost-sharing or matching is required. Key dates include an opening date of August 29, 2025, with multiple rolling deadlines until January 28, 2028. Letters of Intent are due 60 days prior to each application deadline. Submissions must comply strictly with NIH guidelines, and required documents include a Gantt chart, IP strategy, needs assessment, resource checklist, team management plan, and both UG3 and UH3 milestone plans. Applications will be evaluated on the significance and innovation of the proposed device, feasibility of the approach, and expertise and organizational resources. Projects must address a significant clinical need and propose a novel solution that represents a substantial advancement over existing technologies. NIH staff will participate in project negotiation, milestone setting, and ongoing monitoring. Contact information includes Nick Langhals at Blueprint-MedTech@nih.gov and additional contacts for each participating institute. This NOFO is designed to bridge the gap from bench to bedside by supporting device translation through regulatory, clinical, and commercialization milestones, enabling eventual patient access to innovative technologies.

Contact NIH staff early to confirm mission fit and ensure complete, responsive application with all attachments.