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

The Blueprint MedTech Translator program, funded by the National Institutes of Health (NIH), is a milestone-driven cooperative agreement initiative aimed at accelerating the development and clinical translation of innovative medical devices targeting disorders of the nervous system. The program is operated under the auspices of the NIH Blueprint for Neuroscience Research—a collaborative framework uniting twelve NIH Institutes and Centers (ICs)—and includes participation from key institutes such as the National Institute of Neurological Disorders and Stroke (NINDS), the National Eye Institute (NEI), and others. This initiative is also aligned with broader NIH priorities including the BRAIN and HEAL initiatives. The funding opportunity announcement (FOA) number for this initiative is PAR-25-383, and it reissues the prior PAR-21-315. The primary objective of this program is to support the translation of novel therapeutic and diagnostic medical devices from early development to clinical validation. Eligible projects must focus on device development activities leading to FDA Investigational Device Exemption (IDE) for Significant Risk (SR) studies or Institutional Review Board (IRB) approval for Non-Significant Risk (NSR) studies. The program encompasses both non-clinical and clinical research phases. The UG3 phase supports translational activities, while the UH3 phase, contingent on UG3 milestone achievement, supports clinical studies. NIH anticipates substantial involvement in project execution, including negotiation of milestones and active monitoring of progress. Eligible applicants include a wide array of organizations, both domestic and international, such as higher education institutions, for-profit entities, non-profits, tribal governments, and various local government entities. Foreign organizations and components are also eligible. Projects must involve FDA-regulated device technologies that align with the missions of participating ICs. Devices should offer clinical and technological innovations beyond existing standards and must be supported by sufficient preclinical data and stakeholder input. NIH encourages early consultation with FDA and recommends including feedback from regulatory agencies in applications. Applications must include specific components and attachments, such as a Gantt chart, needs assessment, long-term patient care plan, and a comprehensive intellectual property strategy. Applications that fail to include these components or exceed specified page limits will be deemed non-compliant and withdrawn from consideration. Projects proposing delayed-onset clinical studies or lacking a clear regulatory path will also be considered non-responsive. Applications must also demonstrate feasibility for timely FDA or IRB approvals during the UG3 phase, with the UH3 phase focusing on clinical validation, potential commercialization, or further clinical development. The application process involves submission through Grants.gov using NIH ASSIST, institutional S2S, or Workspace. Applications open on August 29, 2025, with due dates every four months through January 28, 2028. Each cycle includes reviews by NIH scientific merit panels and advisory councils, with awards starting approximately seven months after submission. The project period may span up to five years, with a maximum of four years for each phase. Applicants are advised to consult NIH program staff to confirm fit and obtain guidance on application strategy. NIH provides substantial in-kind support through Blueprint MedTech resource providers, offering services such as design optimization, large animal testing, regulatory consulting, and commercialization planning. All clinical studies must adhere to FDA and NIH guidelines for safety, ethical conduct, and data integrity. Milestones are expected to be SMART (Specific, Measurable, Achievable, Relevant, Time-bound), and NIH will evaluate progress annually to determine continuation. Final funding decisions will also consider the competitive landscape, program priorities, and availability of funds. Contact points for programmatic and administrative questions include dedicated personnel from each participating IC, with centralized inquiries directed to [email protected].

Start early; engage program staff to validate alignment with NIH mission and ensure application completeness.