The NIH Blueprint MedTech Translator grant supports translational activities and clinical feasibility studies for therapeutic and diagnostic devices treating nervous or neuromuscular disorders. It funds clinical prototype development, non-clinical testing, and regulatory approval (IDE/IRB) for clinical studies. Open to investigators, institutions, and businesses developing novel medical devices, awardees receive lab funding and access to NIH-funded consultants for regulatory, IP, and commercialization guidance. Specialized testing and manufacturing support are also available via NIH contract research organizations. This milestone-driven program accelerates device development.
Opportunity ID: 358823
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-383 |
| Funding Opportunity Title: | Blueprint MedTech Translator (UG3/UH3 – Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.121 — Oral Diseases and Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jun 17, 2025 |
| Last Updated Date: | Jun 17, 2025 |
| Original Closing Date for Applications: | Jan 28, 2028 |
| Current Closing Date for Applications: | Jan 28, 2028 |
| Archive Date: | Mar 04, 2028 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Special district governments For profit organizations other than small businesses Small businesses Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments State governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education |
| Additional Information on 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 Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| 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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-383.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 358823 Full Announcement-PAR-25-383 -> PAR-25-383-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00290980 | Aug 29, 2025 | Jan 28, 2028 | View |
Package 1
Mandatory forms
358823 RR_SF424_5_0-5.0.pdf
358823 PHS398_CoverPageSupplement_5_0-5.0.pdf
358823 RR_OtherProjectInfo_1_4-1.4.pdf
358823 PerformanceSite_4_0-4.0.pdf
358823 RR_KeyPersonExpanded_4_0-4.0.pdf
358823 RR_Budget10_3_0-3.0.pdf
358823 PHS398_ResearchPlan_5_0-5.0.pdf
358823 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
358823 RR_SubawardBudget10_30_3_0-3.0.pdf
358823 PHS_AssignmentRequestForm_4_0-4.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
