Translational Neural Devices (R61/R33 - Clinical Trial Optional)
National Institutes of Health
Award ceiling
—Award floor
—Posted
Oct 29, 2024Closes
Jan 28, 2027Location eligibility
No specific state restriction found in this listing — check the full opportunity for details.Categories: Health
Eligible applicants: Native American tribal governments (Federally recognized), City or township governments, Public housing authorities/Indian housing authorities, Small businesses, State governments, Others (see text field entitled "Additional Information on Eligibility" for clarification), Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Public and State controlled institutions of higher education, Native American tribal organizations (other than Federally recognized tribal governments), For profit organizations other than small businesses, County governments, Independent school districts, Special district governments
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.