Translational Neural Devices (R61/R33 - Clinical Trial Optional)
OpenNational Institutes of Health · Opportunity number PAR-25-053
Eligibility
Nonprofits are listed as eligible applicants.
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Native American tribal organizations (other than Federally recognized tribal governments)
- County governments
- Public housing authorities/Indian housing authorities
- Small businesses
- Public and state controlled institutions of higher education
- Private institutions of higher education
- City or township governments
- Special district governments
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Native American tribal governments (Federally recognized)
- State governments
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- For profit organizations other than small businesses
- Independent school districts
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Description
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This NOFO is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.
Funding
| Total program funding | Not listed |
|---|---|
| Award floor | Not listed |
| Award ceiling | Not listed |
| Category | Health |
| Assistance listing | 93.853, |
Official sources
Last verified on Grants.gov Nov 4, 2026. Grantvello is not affiliated with Grants.gov or National Institutes of Health. The notice on Grants.gov is the binding text.