Translational Neural Devices (R61/R33 - Clinical Trial Optional)

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.

This opportunity from National Institutes of Health is open to eligible applicants nationwide. Organizations working in Healthcare are especially encouraged to review the requirements.

Federal grant opportunities like this one are typically open to a range of applicant types. Common eligible organizations include:

• Nonprofits and 501(c)(3) organizations
• Small businesses and startups (especially for SBIR/STTR programs)
• State, local, and tribal governments
• Colleges, universities, and research institutions
• Individuals (for select programs in education, arts, and research)

Eligibility requirements vary by opportunity. Always review the official listing before investing time in an application.