Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)
Can you apply?
This grant is for development of next-generation neurotechnology devices for recording and modulating activity in the human central nervous system (brain and spinal cord). Eligible applicants include domestic institutions with NIH/HHS research capabilities, such as universities, medical schools, research hospitals, and research-focused nonprofits. The program supports early-stage device development with optional transition to human clinical trials. Applicants must have access to appropriate laboratory facilities, animal testing capabilities (if applicable), and regulatory expertise for medical device development. The funding focuses on innovative technologies that improve our ability to interface with and modulate neural circuits in living humans. Foreign organizations and individuals without institutional affiliation are typically ineligible unless part of a collaborative agreement with a U.S.-based organization.
This grant is for development of next-generation neurotechnology devices for recording and modulating activity in the human central nervous system (brain and spinal cord). Eligible applicants include domestic institutions with NIH/HHS research capabilities, such as universities, medical schools, research hospitals, and research-focused nonprofits. The program supports early-stage device development with optional transition to human clinical trials. Applicants must have access to appropriate laboratory facilities, animal testing capabilities (if applicable), and regulatory expertise for medical device development. The funding focuses on innovative technologies that improve our ability to interface with and modulate neural circuits in living humans. Foreign organizations and individuals without institutional affiliation are typically ineligible unless part of a collaborative agreement with a U.S.-based organization.
Program 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. 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.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for development of next-generation neurotechnology devices for recording and modulating activity in the human central nervous system (brain and spinal cord). Eligible applicants include domestic institutions with NIH/HHS research capabilities, such as universities, medical schools, research hospitals, and research-focused nonprofits. The program supports early-stage device development with optional transition to human clinical trials. Applicants must have access to appropriate laboratory facilities, animal testing capabilities (if applicable), and regulatory expertise for medical device development. The funding focuses on innovative technologies that improve our ability to interface with and modulate neural circuits in living humans. Foreign organizations and individuals without institutional affiliation are typically ineligible unless part of a collaborative agreement with a U.S.-based organization.
How to apply
Application links
Required documents
- NIH SF-424 application form (R&D component)
- Project narrative/specific aims (3–5 pages)
- Research strategy including innovation, significance, and approach sections
- Budget justification and detailed budget
- Curriculum vitae or biosketch for all key personnel
- Letters of support from collaborating institutions and clinical sites
- Preliminary data or feasibility evidence
- Institutional animal care and use protocol (if animal work planned)
- Regulatory strategy document or FDA pre-submission meeting summary (recommended)
- Conflict of interest disclosures
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.866 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$463,372,200
-
$172,327,224
-
$115,145,694
-
$99,649,073
-
$93,275,174
-
$78,657,309
-
$75,825,492
-
$75,398,895
-
$70,985,470
-
$64,812,576
Top States by Funding
- MI 2 awards $511.9M
- CA 8 awards $511.1M
- MO 8 awards $437.0M
- IN 4 awards $303.9M
- PA 6 awards $298.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.866). How funding has trended year over year.
| 2024 | $3,746,886,731 | |
| 2025 | $3,777,464,644 | |
| 2026 est. | $261,814,471 |
FAQ
What types of organizations can apply?
Eligible applicants include U.S. universities, medical schools, research hospitals, nonprofit research institutions, and other domestic organizations with the capacity to conduct NIH-supported research. Federal laboratories can sometimes apply as collaborators.
What is the UG3/UH3 structure?
The UG3 phase supports exploratory development and feasibility studies (typically 2 years). The optional UH3 phase allows transition to human clinical trials for successful technologies (typically 3 years). Not all awards proceed to UH3.
What types of devices are supported?
The program supports innovative recording devices (electrophysiology, imaging), stimulation/modulation devices (DBS, optogenetics, ultrasound), and hybrid approaches for interfacing with the central nervous system. Technologies must target human applications.
What is the typical funding level?
UG3 awards typically range from $500,000 to $1.5 million over two years, with higher amounts for multi-institutional teams. UH3 amounts are generally larger to support clinical trial operations.
When is the application deadline?
The current deadline is September 28, 2026. NIH typically releases subsequent deadlines on a regular cycle; applicants should monitor grants.nih.gov for updates.
💡 Tips for applicants
- Emphasize the innovation and technical feasibility of your device approach; reviewers want to see how your technology advances beyond existing commercial or research tools available today.
- Include a clear regulatory pathway and timeline—describe FDA classification expectations and any preliminary conversations with regulatory agencies to demonstrate realistic clinical translation planning.
- Establish strong collaborative teams that include neuroengineers, neuroscientists, clinicians familiar with the target patient population, and regulatory/commercialization expertise. Demonstrate that roles are clearly defined.
- Design a rigorous and realistic Phase 1 (UG3) plan with measurable milestones and go/no-go decision points so reviewers understand what success looks like before committing to expensive clinical trials.
- Address both technical risk and implementation risk; discuss how you will handle device failures, safety issues, and ethical considerations in human neural interfaces. Show familiarity with relevant ethical guidelines and institutional oversight.
⚠️ Common mistakes
Applications often underestimate the complexity and timeline required for human clinical translation, leading to unrealistic Phase 2 plans. Weak regulatory strategy is a frequent pitfall—reviewers want evidence that you understand FDA requirements and have a credible pathway to approval. Lack of strong clinician co-investigators or insufficient discussion of the target patient population's clinical need can also result in rejection.
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