Opportunity Information: Apply for PAR 21 315
Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional) is a National Institutes of Health (NIH) cooperative agreement funding opportunity designed to move promising neurotechnology and neuromuscular device concepts out of the lab and toward real-world use. The core aim is practical translation: supporting the engineering, testing, and regulatory groundwork needed to advance therapeutic and diagnostic devices intended for disorders affecting the nervous system or neuromuscular systems. Rather than funding basic discovery science, this program is built for teams who already have a credible device concept and need focused resources to turn it into a clinically testable product.
The work supported spans the kinds of activities that typically sit between an academic prototype and an early human study. That includes building or refining a clinical prototype, running non-clinical safety and efficacy tests (which may include bench and animal work), and completing design verification and validation so the device is better aligned with regulatory and clinical expectations. A major emphasis is preparing to enter the clinic appropriately, either by obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) clinical study or securing Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study. After those steps, the award can support a clinical feasibility study when the key information needed (about device function, usability, or final design) cannot realistically be obtained through additional non-clinical assessments due to the novelty of the device or how it will be used in patients. In other words, the clinical portion is meant to answer design-critical questions that only a carefully scoped human study can answer, not to serve as a large pivotal trial.
Mechanistically, this FOA uses the UG3/UH3 structure and is milestone-driven. The UG3 phase is generally associated with completing specified, measurable development and readiness milestones (for example, prototype finalization, V and V planning/execution, preclinical packages, and regulatory preparation). Transition to the UH3 phase is tied to successfully meeting those milestones and typically supports the next stage, which can include the clinical feasibility study. Because this is a cooperative agreement, NIH staff are not hands-off funders; they take an active role in negotiating the final project plan before award and monitoring progress during execution. Applicants should expect clear deliverables, go/no-go decision points, and regular project oversight.
A distinctive feature of Blueprint MedTech is the built-in translational support ecosystem layered on top of direct funding. Awardees receive funds for the activities they conduct in their own labs and organizations, but they also collaborate with NIH-funded consultants who can advise on areas that often slow device translation: regulatory strategy, reimbursement considerations, intellectual property, commercialization planning, and building strategic partnerships. On top of that, teams may be able to augment their projects using NIH contract research organizations (CROs) with specialized capabilities such as large animal testing, sterilization testing, biocompatibility assessments, manufacturing-related support, and medical monitoring. This structure is meant to reduce common bottlenecks and help investigators build a more complete, investor- and regulator-ready development package.
Eligibility is broad and includes many types of applicants across academia, government, nonprofits, and industry. Eligible entities include state 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 small businesses), and other organizations. The FOA also explicitly welcomes applications from a wide range of mission-serving and community-based institutions and entities, including HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations. The announcement encourages both groups developing devices independently and groups already collaborating with device manufacturers to apply, and it notes there are companion opportunities in the broader Blueprint MedTech program.
From an administrative standpoint, this opportunity is listed as PAR-21-315, offered by NIH, and uses the cooperative agreement funding instrument. It sits within health-related federal assistance (CFDA listings include multiple NIH program numbers, reflecting participation across NIH components involved in neuroscience and neuromuscular disease areas). The original closing date shown is 2024-09-27. Award ceiling and expected award counts are not specified in the provided source details, which usually means applicants should rely on the full FOA text and NIH communications for current budget and award planning expectations.
In practical terms, the best-fit projects are those with a defined device concept and a realistic, milestone-based plan to reach a clinical prototype, complete the needed non-clinical and verification work, align with FDA/IRB requirements, and (when justified) run a tightly designed clinical feasibility study that directly informs the final device design or function. The program is deliberately structured to help teams navigate the full translation path, not just pay for experiments, by pairing funding with hands-on NIH involvement and access to specialized expertise in the areas that determine whether a device can actually reach patients.Apply for PAR 21 315
- 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 2021-08-20.
- Applicants must submit their applications by 2024-09-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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.
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