Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional) | PAR 25 383

Opportunity Information: Apply for PAR 25 383

Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional) is an NIH cooperative agreement opportunity designed to move promising therapeutic and diagnostic medical devices for nervous system or neuromuscular disorders from late-stage development into early clinical testing. The program is built for teams that are beyond basic discovery and are ready to tackle the practical steps needed to translate a device toward real-world use, including building and refining clinical-grade prototypes and generating the evidence needed to justify first-in-human or other clinical feasibility work. While a clinical trial component is optional, the announcement is clearly oriented toward projects where a carefully scoped clinical feasibility study is either planned or strongly supported by the work completed under the award.

The scope of work centers on hands-on translational activities that reduce risk and prepare a device for clinical evaluation. Supported activities include clinical prototype implementation, non-clinical safety and efficacy testing, and the design verification and validation work typically required to demonstrate that a device meets its engineering and performance specifications. The program also supports the regulatory and ethics pathway work that must happen before enrolling participants, such as obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or securing Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study. If a clinical feasibility study is proposed, it is expected to answer key questions about device function, usability, or final design decisions that cannot realistically be resolved through additional bench testing or animal studies, often because the device is novel or the intended use demands human data to finalize design choices.

Mechanistically, this is a milestone-driven UG3/UH3 cooperative agreement, meaning NIH is not simply issuing funds and stepping back. Applicants should expect active engagement from NIH program staff, including negotiation of the final project plan before an award is made and ongoing monitoring of progress against defined milestones. This structure is meant to keep projects moving toward clear go/no-go decision points and to ensure that funded efforts remain aligned with a realistic translation and feasibility-testing pathway rather than open-ended research.

A distinguishing feature of the Blueprint MedTech program is the combination of direct project funding with structured, NIH-supported development assistance. Awardees receive funding for activities carried out in their own laboratories, but they also collaborate with NIH-funded consultants who can provide expertise in areas that often slow device translation, such as regulatory strategy, reimbursement considerations, intellectual property planning, commercialization approaches, and building strategic partnerships. On top of that, participants may be able to augment their project by leveraging NIH contract research organizations with specialized capabilities, including large animal testing, sterilization testing, biocompatibility assessment, manufacturing-related support, and medical monitoring. The intent is to give investigators a more complete translational ecosystem rather than expecting each team to independently assemble every capability required for a credible clinical-ready package.

The opportunity is open to a wide range of applicant organizations, reflecting NIH's interest in supporting device translation across academia, government, nonprofits, and industry. Eligible applicants include state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses. The announcement also explicitly calls out additional eligible applicant categories such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and even non-U.S. (foreign) entities and regional organizations, which signals broad eligibility as long as the proposed work fits the program goals.

Administratively, the sponsoring agency is the National Institutes of Health, and the funding instrument is a cooperative agreement under a discretionary program category. The opportunity number is PAR-25-383, and it lists multiple CFDA numbers tied to participating NIH institutes and centers (93.121, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867). The original closing date is shown as January 28, 2028, indicating a multi-year window in which applications may be accepted according to the announcement's schedule. Applicants who are developing their own devices, as well as those who already have manufacturing collaborations in place, are encouraged to apply either to this notice of funding opportunity or to related companion opportunities referenced through the Blueprint MedTech program.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2025-06-17.
• Applicants must submit their applications by 2028-01-28.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 383

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