Translational Neural Devices (R61/R33 - Clinical Trial Optional) | PAR 24 151

Opportunity Information: Apply for PAR 24 151

The NIH funding opportunity "Translational Neural Devices (R61/R33 - Clinical Trial Optional)" (PAR-24-151) is a discretionary grant program designed to push promising neural and neuromuscular devices past early feasibility stages and toward real-world clinical use. Its central focus is on translational work that directly advances therapeutic or diagnostic devices intended for disorders of the nervous system or neuromuscular system. Rather than supporting basic discovery science, this FOA is aimed at the practical, development-focused steps needed to move a device from a credible prototype into a state where it can be tested in humans, refined, and positioned for later-stage clinical evaluation or broader adoption.

The program supports a connected set of activities that typically sit between late preclinical development and early clinical evaluation. Examples include building or implementing clinical prototype devices, performing non-clinical safety and efficacy testing, and completing design verification and validation work that demonstrates the device performs as intended and meets defined requirements. A key feature is support for regulatory and oversight preparation, including work to obtain an Investigational Device Exemption (IDE) when the planned study is considered Significant Risk (SR), or to obtain Institutional Review Board (IRB) approval when the study is considered Non-Significant Risk (NSR). After these enabling steps, the program can support a subsequent small clinical study. While clinical trials are described as optional, the FOA clearly anticipates that many projects will culminate in a small human study when that is the most realistic way to answer critical questions about function, usability, safety signals, or final design decisions.

The small clinical study component is intended to be purposeful and tightly justified. NIH is looking for situations where human testing is necessary because the device is novel or its intended use cannot be adequately evaluated through additional benchtop tests or animal studies. In other words, the clinical work should not be a routine next step done for its own sake; it should be designed to generate information that materially de-risks the technology, confirms key aspects of performance, or informs final design choices in ways that non-clinical studies cannot practically accomplish.

Mechanistically, this FOA uses the R61/R33 phased approach within a cooperative agreement, and it is explicitly milestone-driven. In practice, that means applicants are expected to lay out concrete, measurable milestones that define technical progress and decision points. NIH program staff play an active role compared with a standard investigator-initiated grant: they participate in negotiating the final project plan before award and then monitor progress against the agreed milestones over the life of the project. This structure is meant to keep projects focused on deliverables typical of device translation, such as validated prototypes, completed verification/validation packages, regulatory submissions or approvals, and clearly interpretable results from any supported clinical study.

Eligibility is broad and includes many organization types commonly involved in device development and translational research. Eligible applicants include state, county, and local 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; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations), reflecting an intent to draw from a wide ecosystem of developers, clinical partners, and translational teams.

Administratively, the opportunity is run by the National Institutes of Health under CFDA number 93.853. The original closing date listed is January 28, 2027. While the provided source data does not specify an award ceiling or expected number of awards, the overall framing signals a competitive, development-oriented program where a strong application will likely emphasize a clear clinical need, a credible device development and testing plan, a realistic regulatory/oversight pathway (IDE for SR studies or IRB approval for NSR studies), and well-defined milestones that demonstrate readiness to translate the device into an early clinical setting when appropriate.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Translational Neural Devices (R61/R33 - 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 2024-02-23.
• Applicants must submit their applications by 2027-01-28.
• 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 24 151

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