Grant opportunity · PAR-25-053
Translational Neural Devices (R61/R33 - Clinical Trial Optional)
Who can apply (as listed)
- Private institutions of higher education
- Independent school districts
- Public housing authorities / Indian housing authorities
- Small businesses
- Others (see the opportunity text)
- County governments
- For-profit organizations (other than small businesses)
- Nonprofits with 501(c)(3) status (other than institutions of higher education)
- Nonprofits without 501(c)(3) status (other than institutions of higher education)
- City or township governments
- Special district governments
- Native American tribal governments (federally recognized)
- Native American tribal organizations (other than federally recognized governments)
- State governments
- Public and state-controlled institutions of higher education
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 pro…
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