BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)
About
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. 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.
The BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional) is a federal grant program designed for researchers and organizations developing innovative medical devices for nervous system and neuromuscular disorders. This milestone-driven cooperative agreement supports the translational pathway from concept to clinical application, making it ideal for biomedical entrepreneurs, research institutions, and medical device developers ready to advance their technologies. The program funds implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and Investigational Device Exemption (IDE) applications for Significant Risk studies. Applicants can pursue small clinical studies to gather critical information about device function and design that cannot be obtained through laboratory or animal testing alone. This is particularly valuable for novel devices addressing unmet clinical needs in neurology and neuromuscular medicine. The NIH provides ongoing support through program staff collaboration on project planning and progress monitoring, ensuring your device development stays aligned with regulatory and scientific standards. Eligible applicants include universities, federal agencies, faith-based organizations, and minority-serving institutions nationwide, making this an accessible opportunity for diverse research teams.
Funding Facts
● Applications openDeadline
September 28, 2026
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by project scope
Deadline
2026-09-28
Grant Type
federal
Application Cycle
Annual with September 28, 2026 deadline
Best For
Biomedical researchers, medical device developers, universities, minority-serving institutions, and organizations advancing novel nervous system diagnostic and therapeutic devices
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 BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)?
Eligible applicants include universities and research institutions, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), eligible federal agencies, faith-based or community-based organizations, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Indian/Native American Tribal Governments. For complete eligibility requirements and institutional certifications, visit the official NIH announcement page.
How much funding does BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional) provide?
Specific funding amounts are not listed in the current program details. Award amounts may vary based on the scope of your project, development stage, and clinical trial requirements. Contact the NIH program officer or visit the official FOA announcement for current funding levels and budget guidelines.
How do I apply for BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)?
Applications are submitted through the official NIH grants portal. As a milestone-driven cooperative agreement, the process involves submitting your proposal, negotiating a final project plan with NIH program staff before award, and ongoing progress monitoring. Visit the NIH BRAIN Initiative website and the specific Funding Opportunity Announcement (FOA) for application instructions, required forms, and the current deadline of September 28, 2026.
What can BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional) funding be used for?
Funding supports translational activities and small clinical studies for therapeutic and diagnostic devices targeting nervous system and neuromuscular disorders. Eligible uses include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for Significant Risk studies, and conducting subsequent small clinical studies to gather critical device performance data.
Last updated: July 5, 2026