Translational Neural Devices (UG3/UH3 - Clinical Trial Optional) | RFA NS 21 021

Opportunity Information: Apply for RFA NS 21 021

The NIH funding opportunity "Translational Neural Devices (UG3/UH3 - Clinical Trial Optional)" (RFA-NS-21-021) is designed to help teams move promising therapeutic or diagnostic devices for nervous system and neuromuscular disorders from late-stage development into practical, testable products, including the option to run a small clinical study when it is truly needed. The emphasis is on translational work that pushes a device toward real-world use rather than early discovery research. In practice, this means supporting the kind of engineering, testing, regulatory preparation, and limited human evaluation that can reduce uncertainty about whether a device works as intended and is ready for larger clinical validation or commercialization pathways.

The FOA supports a broad range of development activities that are common bottlenecks for neural and neuromuscular devices. Funded projects can include building and refining a clinical prototype; conducting non-clinical safety and efficacy testing (for example, benchtop verification, animal studies when appropriate, biocompatibility, electrical safety, software testing, and other performance assessments); and completing design verification and validation activities that demonstrate the device meets specifications and user needs. The announcement also explicitly includes regulatory and ethics steps needed to begin human research, such as preparing for and 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. After those steps, the program can support a subsequent small clinical study intended to answer focused questions about device function, usability, feasibility, or final design choices.

A key theme is that any clinical study under this program should be tightly justified and should generate information that cannot realistically be obtained through additional non-clinical testing. In other words, the clinical component is not meant to replace thorough bench or animal work, and it is not meant for large pivotal trials. Instead, it is meant for situations where the novelty of the device or its intended use makes it impractical to fully characterize performance without limited human use, such as evaluating real-world signal quality, stimulation tolerability, workflow integration, or other human factors that directly affect final design decisions.

This FOA uses the UG3/UH3 structure and is run as a cooperative agreement, which signals a more hands-on partnership with NIH than a standard research grant. Projects are milestone-driven, meaning applicants are expected to propose clear, measurable technical and regulatory milestones, and NIH program staff will work with awardees to negotiate and finalize the project plan before funding begins. NIH staff also monitor progress over time, and continued support is typically tied to meeting agreed-upon milestones. This structure is intended to keep projects focused on concrete development outcomes and to reduce the risk of drifting into open-ended research that does not translate into a usable device.

From an administrative standpoint, the opportunity is categorized as discretionary funding, with a cooperative agreement as the funding instrument and a health-related funding activity area under CFDA 93.853. The listing includes an award ceiling of $1,000,000. The original closing date shown is 2024-02-20, and the opportunity was created on 2021-04-28. The expected number of awards is not specified in the provided details.

Eligibility is broad and includes many organization types that commonly participate in device development and translational research. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations (including those other than federally recognized governments); public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also calls out additional eligible groups, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIS institutions, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). Overall, the eligibility language reflects an intent to attract multidisciplinary teams across academia, industry, and community-centered or government-affiliated organizations that can realistically deliver a prototype, complete testing and regulatory steps, and, when justified, conduct a small human study.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Translational Neural Devices (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): 93.853.
• This funding opportunity was created on 2021-04-28.
• Applicants must submit their applications by 2024-02-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
• 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 RFA NS 21 021

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