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. * The program is a milestone-driven cooperative agreement program. * It will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. * The opportunity is open to various applicant types, including nonprofits, small businesses, and institutions of higher education. * The expected application count is 100. * The application size is not specified. * The opportunity is electronic and requires the use of the eRA Service Desk for support.