This opportunity supports translational development of neural and neuromuscular therapeutic or diagnostic devices, including completing prototype verification/validation, non-clinical safety and efficacy testing, and moving toward human testing. Applicants may conduct small clinical studies when key device functionality or final design information can’t be obtained from bench or animal studies, including steps like securing IRB approval or an IDE for a significant-risk study. It is milestone-driven and coordinated through a cooperative agreement model with active program staff involvement.

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.