Translational Neural Devices (R61/R33 – Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for academic researchers, institutions, and biotech companies seeking to develop and translate neural interface technologies toward clinical application. The NIH National Institute of Neurological Disorders and Stroke (NINDS) supports projects ranging from proof-of-concept through early-stage clinical trials for brain-computer interface (BCI) and neural recording/stimulation devices. Eligible applicants typically include universities, medical centers, research hospitals, small businesses, and other research institutions with appropriate institutional infrastructure. The two-phase R61/R33 mechanism allows investigators to test feasibility in Phase 1 (R61) before committing to larger Phase 2 (R33) development efforts. The program is national in scope and does not restrict geographic location. Activities supported include preclinical device development, biocompatibility testing, animal studies, IND-enabling studies, pilot human safety studies, and optional early clinical trials for devices demonstrating sufficient promise.
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Program description
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.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) form and face page
- Project narrative (typically 12 pages for R61, structured background, innovation, specific aims, preliminary data, and translational pathway)
- Biographical sketches for key personnel (NIH format, 4 pages maximum per person)
- Budget and budget justification
- Facilities and administrative resources description
- Letters of support from collaborators, clinical partners, or manufacturers (if applicable)
- Supporting documentation: preliminary data figures, animal protocol approvals, IRB letters, regulatory correspondence, letters of collaboration from clinical sites
- Data management and sharing plan (if applicable to device development)
- Resource sharing plan for any software or validated tools developed
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.853 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$56,144,651
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$40,959,789
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$35,655,349
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$35,655,116
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$35,335,145
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$34,183,297
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$32,294,153
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$32,234,840
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$31,739,294
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$27,282,286
Top States by Funding
- MA 5 awards $123.9M
- OH 4 awards $112.5M
- CA 4 awards $101.3M
- FL 3 awards $100.3M
- MI 3 awards $85.3M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.853). How funding has trended year over year.
| 2024 | $2,362,835,459 | |
| 2025 | $2,345,500,401 |
FAQ
Who is eligible to apply for this grant?
Universities, medical schools, teaching hospitals, research institutes, small businesses (including minority-owned and woman-owned), and other organizations with research capacity in neuroscience or biomedical engineering can apply. Both foreign and domestic institutions may be eligible depending on NIH rules in effect at application time.
What is the R61/R33 two-phase structure?
The R61 phase (typically 2 years) supports feasibility and preliminary development work. Successful R61 grantees can transition to the R33 phase (typically 3 years) for scaled development, manufacturing scale-up, and clinical preparation or early trials without competing for new funding.
What kind of activities and devices are supported?
Eligible projects include implantable and non-implantable neural interfaces (BCIs, recording arrays, stimulation systems), biocompatibility optimization, surgical approaches, signal processing algorithms, and early human studies. Clinical trial components are optional but increasingly emphasized for projects with clinical readiness.
How competitive is this program?
This is a highly competitive NIH mechanism. Success typically requires preliminary data demonstrating technical feasibility, a clear translational pathway, experienced team with complementary expertise, and realistic timelines. Scientific innovation and feasibility of proposed approach are critical.
What is the typical funding range?
R61 phase awards typically range from $250K–$400K annually depending on complexity; R33 phase awards are higher, often $350K–$600K+ annually. Budget and justification must align with project scope and institutional facilities.
💡 Tips for applicants
- Build a strong multidisciplinary team: include neuroscientists, engineers, clinicians, and regulatory experts. NIH reviewers expect collaborative expertise spanning device development, neuroscience, and clinical translation.
- Lead with preliminary data: Show proof-of-concept results (animal models, bench tests, or preliminary human feasibility data) that demonstrate technical merit and de-risk the approach. Reviewers are skeptical of purely theoretical proposals.
- Address regulatory pathway early: Include a realistic plan for FDA interactions (IND pathway, 510(k) strategy, or breakthrough device designation if applicable). Demonstrate awareness of manufacturing, biocompatibility, and safety requirements.
- Be explicit about clinical translation: Even if clinical trials are optional, explain why your device has clinical relevance, what unmet medical need it addresses, and how you will transition from R61 to R33 phase activities.
- Plan for a strong R61→R33 transition: In your R61 proposal, outline specific milestones and go/no-go decision criteria that will qualify you for R33 continuation. Reviewers want confidence that you will meet feasibility goals.
⚠️ Common mistakes
Applicants often submit overly ambitious clinical timelines or claim clinical efficacy without adequate preclinical validation. Reviewers frequently reject proposals lacking a clear regulatory strategy or insufficient detail on device safety, biocompatibility, and manufacturing feasibility. Weak team composition—especially absence of clinical expertise or prior device development experience—is a common reason for unfavorable scores.
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