Blueprint MedTech Translator (UG3/UH3 – 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 researchers and organizations developing medical devices for nervous and neuromuscular system disorders. Eligible applicants include individuals, institutions, businesses, non-profits, federal agencies, faith-based organizations, and tribally controlled entities. Projects can focus on device design, prototype testing, regulatory approval (IDE/IRB), and clinical feasibility studies. Applicants work in their own labs with support from NIH consultants and contract research organizations.
Individuals developing devices independently or those collaborating with manufacturers can apply directly. Foreign organizations, territory-based entities, and minority-serving institutions are also eligible. Cost-sharing is not required.
Activities must advance therapeutic or diagnostic devices and provide clinical data that cannot be obtained through non-clinical testing alone. The program emphasizes milestone-driven progress with ongoing NIH oversight and input.
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Program description
The purpose of this announcement is to encourage investigators to pursue translational activities and clinical feasibility 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 clinical feasibility 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. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this NOFO or any of the companion opportunities. For more information see BP MedTech website.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) form
- Project Narrative
- Budget and Budget Narrative
- Biosketches (key personnel)
- Resources and Environment
- Device technical specifications/drawings
- Regulatory strategy and timeline
- Clinical study protocol (if applicable)
- Letters of support from clinical/manufacturing partners (if applicable)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.279 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$204,359,786
-
$128,078,833
-
$126,585,435
-
$99,478,296
-
$79,333,238
-
$78,351,755
-
$74,806,844
-
$71,588,047
-
$61,578,651
-
$50,952,037
Top States by Funding
- NY 4 awards $260.8M
- WA 1 awards $204.4M
- CT 2 awards $155.8M
- CA 4 awards $141.1M
- MD 2 awards $128.2M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.279). How funding has trended year over year.
| 2024 | $1,245,503,136 | |
| 2025 | $1,343,517,098 | |
| 2026 est. | $20,194,375 |
FAQ
Who can apply to this grant?
Individuals, institutions, businesses, nonprofits, federal agencies, and foreign organizations can apply. You must be developing your own device or have an established collaboration with a device manufacturer.
What activities are supported?
The program funds prototype implementation, safety/efficacy testing, design validation, IDE/IRB approval, and clinical feasibility studies. You work in your own lab with NIH consultant support.
Is cost-sharing required?
No, cost-sharing is not required for this program.
How is this program different from traditional NIH grants?
This is a milestone-driven cooperative agreement. NIH staff negotiate your project plan before funding and monitor progress throughout the award.
What kind of device support is available?
Beyond lab funding, NIH provides consultants for regulatory, reimbursement, IP, and commercialization guidance. Contract organizations can assist with animal testing, manufacturing, and sterilization.
💡 Tips for applicants
- Define which nervous/neuromuscular disorder your device addresses and explain why clinical testing is essential. Non-clinical data alone won't suffice.
- Build a realistic timeline around FDA regulatory milestones (IDE approval, clinical safety review). Frame your project plan in observable, measurable checkpoints.
- Identify your commercialization pathway early. Show how NIH-provided consultants will help you move toward market or reimbursement.
- Propose a clinical feasibility study that directly answers device design or function questions. Avoid vague endpoints.
- Connect with potential device manufacturers or clinical partners before submitting if you haven't already. This strengthens credibility.
⚠️ Common mistakes
Proposing clinical studies that duplicate information already available from bench testing or preclinical studies. Under-estimating regulatory timelines or IDE approval complexity. Failing to specify which NIH consultant expertise (regulatory, reimbursement, IP, commercialization) will directly support your device development.
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