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

The Department of Health and Human Services, through the National Institutes of Health, has reissued the Blueprint MedTech Translator program under announcement number PAR-25-383. This program operates as a UG3/UH3 phased cooperative agreement mechanism and supports translational and clinical research aimed at advancing medical devices to prevent, monitor, diagnose, or treat conditions within the mission of multiple participating NIH Institutes and Centers, as well as the BRAIN and HEAL initiatives. Participating Institutes include the National Institute of Neurological Disorders and Stroke, National Eye Institute, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Biomedical Imaging and Bioengineering, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Dental and Craniofacial Research, National Institute on Drug Abuse, National Institute of Mental Health, and the National Center for Complementary and Integrative Health. Additional co-funding may be provided by NIH offices such as the Office of Behavioral and Social Sciences Research. The program’s purpose is to support investigators developing novel medical device technologies that will advance patient care by addressing unmet diagnostic and therapeutic needs. Activities funded under the UG3 phase include prototype development, safety and efficacy testing, design verification and validation, and preparation of regulatory submissions such as an IDE or IRB approval. The UH3 phase supports clinical studies and feasibility or pivotal trials designed to generate critical data on device performance. Projects must demonstrate a path to clinical adoption, and the total combined duration of UG3 and UH3 phases may not exceed five years. Milestones are required for both phases and serve as go/no-go decision points during annual NIH administrative review. Applicants must submit comprehensive supporting data and a detailed plan for technology translation. The program requires mandatory attachments such as a Gantt chart, intellectual property strategy, needs assessment, long-term patient care plan, resource checklist, and team management plan. Optional attachments may include schematics, IRB communications, and FDA communications. The program emphasizes adherence to FDA design control and quality system requirements, as well as data management and sharing policies consistent with FAIR principles. Intellectual property protection and commercialization planning are strongly encouraged, and applicants must describe how stakeholders, including patients and clinicians, are engaged in development. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, small businesses, state and local governments, tribal governments, independent school districts, public housing authorities, and certain foreign organizations. Foreign components of U.S. organizations may also apply. Individuals with appropriate skills and resources may serve as principal investigators. Cost sharing is not required, and applicant organizations may submit multiple distinct applications. Registrations with SAM.gov, Grants.gov, and eRA Commons are required prior to submission. The earliest application date is August 29, 2025, with multiple receipt dates through January 28, 2028. Applications are due by 5:00 PM local time, with letters of intent strongly encouraged at least 60 days prior to submission. Review cycles will follow NIH peer review procedures, with initial merit review, advisory council consideration, and earliest start dates beginning in July 2026. The program expires January 29, 2028. Applicants requesting $500,000 or more in direct costs in any year must contact NIH staff at least six weeks prior to submission. Applications will be evaluated on importance of research, rigor and feasibility, and expertise and resources. Additional review will focus on long-term patient care, ethical considerations, IP strategy, and alignment with programmatic priorities. NIH program staff will actively monitor projects, negotiate milestones, and may discontinue funding if progress is not achieved. Contacts for scientific and administrative inquiries include Dr. Nick Langhals at NINDS, Dr. Leonardo Angelone at NIDA, Dr. Erin Burke Quinlan at NCCIH, and other listed institute-specific staff, as well as the Chief Grants Management Officer at NINDS for fiscal questions. Full contact details are provided in the announcement.