Description
The purpose of this announcement 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, as well as a subsequent small clinical study. Key aspects of this opportunity include:
• Advancing the development of therapeutic and diagnostic devices for nervous or neuromuscular system disorders
• Supporting translational activities and small clinical studies
• Involving NIH program staff in negotiating the final project plan before award and monitoring of research progress
• Requiring a cooperative agreement program