Translational Neural Devices (UG3/UH3 - Clinical Trial Required) | RFA NS 18 011

Opportunity Information: Apply for RFA NS 18 011

The Translational Neural Devices (UG3/UH3 - Clinical Trial Required) funding opportunity (RFA-NS-18-011) is a National Institutes of Health (NIH) cooperative agreement designed to move promising neural and neuromuscular device concepts out of the lab and into early, practical clinical testing. It targets both therapeutic and diagnostic devices intended for disorders affecting the nervous system or neuromuscular function. The central idea is to fund the kind of focused, milestone-driven development work that bridges the gap between proof-of-concept research and the regulatory and clinical evidence needed to support commercialization or final design decisions.

The program is structured in two linked phases under the UG3/UH3 mechanism. The UG3 phase supports translational development activities such as bench testing, engineering refinement, verification and validation work, and animal studies when appropriate. These efforts are expected to mature the device to the point where the project is ready for a key regulatory step: either submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA), or submission to an Institutional Review Board (IRB) for a Non-Significant Risk (NSR) clinical study determination and approval. In other words, the UG3 period is meant to generate the nonclinical package and documentation that makes a first-in-human or early clinical evaluation feasible and compliant.

If UG3 milestones are met, the project can transition into the UH3 phase, which supports the subsequent small clinical study. This clinical study is not optional under the announcement; it is required. The goal of the clinical portion is to collect initial safety and effectiveness data that can either support a future marketing application (for example, contributing evidence relevant to FDA submissions) or guide final device iteration by clarifying performance, usability, and real-world function in the intended patient population. The clinical study is described as "small," reflecting that this program is aimed at early clinical evidence generation rather than large pivotal trials, but it is still intended to produce decision-quality data for regulatory strategy and product development.

Because this is a cooperative agreement, NIH expects to have substantial scientific and programmatic involvement during the award. In practice, that usually means the project is managed with clear go/no-go milestones, regular progress interactions, and active coordination to keep the work aligned with translational objectives and regulatory expectations. The emphasis is less on exploratory science for its own sake and more on disciplined product development leading to an actionable clinical and regulatory outcome.

The opportunity falls under the Health activity category (CFDA 93.853). The posted award ceiling is $1,000,000, indicating a cap on the maximum award amount under the announcement as listed in the source data. The original closing date shown is 2021-02-22, and the FOA record indicates a creation date of 2017-11-08.

Eligibility is broad and includes many organization types that commonly participate in medical device translation. Eligible applicants include state, county, city or township governments; 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3), other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations).

Overall, this FOA is aimed at teams that already have a credible device concept and are ready to do the hard translational work: rigorous preclinical and engineering development, preparation for IDE or NSR clinical entry, and execution of a tightly scoped clinical study that generates early human data. The expected end state is a device program that is substantially closer to real-world deployment, either by supporting a future marketing path or by producing the evidence needed to finalize the device design before larger clinical investment.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Translational Neural Devices (UG3/UH3 - Clinical Trial Required)" 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 2017-11-08.
• Applicants must submit their applications by 2021-02-22. (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 18 011

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