The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) 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 leading to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) 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 FOA 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.
Companion FOA: RFA-NS-21-021 - Translational Neural Devices (UG3/UH3 Clinical Trial Optional)
Deadlines:
RFA-NS-21-022 Expiration Date: February 21, 2024
December 20, 2022 - Notice of Early Expiration of RFA-NS-21-022 "Translational Neural Devices (U44 Clinical Trial Optional)". See Notice NOT-NS-23-055
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity.
Applicants should rarely exceed $1,000,000 in total costs per year during the SBIR Phase I and $1,500,000 in total costs per year during the SBIR Phase II.
