Translational Neural Devices (R61/R33 - Clinical Trial Optional)
About
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.
The Translational Neural Devices (R61/R33 - Clinical Trial Optional) grant program is designed for investigators and organizations developing innovative therapeutic and diagnostic devices for nervous system and neuromuscular disorders. This NIH-funded opportunity supports the critical bridge between laboratory research and real-world clinical application. If you're working on neural or neuromuscular device technology, this grant can fund prototype implementation, non-clinical safety and efficacy testing, design verification and validation, and importantly, small-scale clinical studies. The program is particularly valuable for developers who need to gather clinical data that cannot be obtained through bench-top or animal testing alone. Eligible applicants include academic institutions, federal agencies, community-based organizations, HBCUs, Hispanic-serving institutions, and other underrepresented serving organizations. This is a milestone-driven cooperative agreement, meaning NIH staff will actively participate in project planning and progress monitoring, providing valuable guidance throughout development. If you have a novel neural device concept ready for translational advancement and need structured support to move toward clinical validation, this program offers both funding and expert collaboration.
Funding Facts
● Applications openDeadline
January 28, 2027
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by cycle and project scope
Deadline
2027-01-28
Grant Type
federal
Application Cycle
Annual with specific deadline (January 28, 2027)
Best For
Investigators and organizations developing neural and neuromuscular therapeutic and diagnostic devices ready for translational advancement and clinical validation
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Govern
Frequently Asked Questions
Who is eligible for Translational Neural Devices (R61/R33 - Clinical Trial Optional)?
Eligible applicants include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), eligible federal agencies, faith-based and community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), and Indian/Native American Tribal Governments. Other eligible applicants may also qualify. For complete eligibility requirements and specific organizational details, visit the official NIH funding opportunity announcement.
How much funding does Translational Neural Devices (R61/R33 - Clinical Trial Optional) provide?
Specific funding amounts vary and were not listed in the current program details. Award amounts typically depend on the scope and phase of your project. Visit the official NIH NOFO (Notice of Funding Opportunity) for current funding ranges and budget guidelines for the R61/R33 mechanism.
How do I apply for Translational Neural Devices (R61/R33 - Clinical Trial Optional)?
Applications are submitted through the official NIH grants portal. Your application should outline your neural or neuromuscular device development plan, including prototype implementation, safety and efficacy testing, and if applicable, your clinical trial strategy. As this is a milestone-driven cooperative agreement, be prepared to work with NIH program staff to negotiate your final project plan before award. Visit the official NIH website for detailed application instructions, required forms, and the specific submission deadline.
What can Translational Neural Devices (R61/R33 - Clinical Trial Optional) funding be used for?
Funding supports clinical prototype device implementation, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for Significant Risk studies or IRB approval for Non-Significant Risk studies, and conducting small clinical studies. The clinical study component is designed to provide device function and design information that cannot be obtained through bench-top or animal testing due to device novelty or intended use.
Last updated: July 5, 2026