NIH Blueprint for Neuroscience Research Education Program on Translational Devices (R25 Clinical Trial Not Allowed) | RFA NS 20 003

Opportunity Information: Apply for RFA NS 20 003

The NIH Blueprint for Neuroscience Research Education Program on Translational Devices (R25 Clinical Trial Not Allowed), funding opportunity number RFA-NS-20-003, is a National Institutes of Health research education grant designed to strengthen the pipeline of people who can successfully move neuroscience-related medical devices from an early concept to real-world clinical use. The core purpose is educational rather than product-development funding: it supports the creation and delivery of a structured short course that teaches the practical, step-by-step process of medical device development and translation for devices intended to diagnose or treat disorders of the nervous system. As an R25, the emphasis is on curriculum, instruction, and building translational know-how across a community of researchers and innovators, rather than on conducting clinical trials or running a device development program.

The program asks applicants to develop and implement a short course that covers three main elements. First, it should lay out the stages required for successful medical device development and translation, which typically include defining the clinical need and intended use, understanding users and clinical workflows, establishing design requirements, iterative prototyping and verification/validation planning, risk management and human factors considerations, regulatory strategy (often involving FDA pathways), quality systems, reimbursement and coding considerations, clinical evidence planning (without conducting a clinical trial under this FOA), intellectual property strategy, manufacturing and scale-up, and commercialization or deployment planning. Second, the course should address common technical and strategic challenges that regularly derail device translation, such as poorly defined use cases, mismatch with clinical workflow, underestimating safety and biocompatibility constraints, unclear regulatory classification, inadequate documentation for design controls, weak evidence plans, unrealistic timelines and budgets, and misalignment between academic incentives and product development needs. Third, it should teach best practices and point trainees to concrete resources for each stage, such as template documents, case studies, regulatory guidance resources, design control checklists, quality management basics, stakeholder interview methods, and pathways for engaging with regulators, investors, clinical partners, and technology transfer offices.

A distinctive feature of this opportunity is its broad intended audience. The short course is expected to serve senior postdoctoral fellows, independent academic researchers, clinician-scientists, and small business entrepreneurs who are interested in translating device ideas in the neuroscience space. In practice, that means the course should be accessible to participants with different starting points: some may understand the clinical problem but not product development, others may be strong engineers without regulatory or reimbursement context, and others may be early founders needing a clearer roadmap for de-risking and partnership. The FOA also allows applicants to include an extended mentorship plan if they believe it will strengthen outcomes, which could take the form of office hours, project-focused feedback, matching participants with experienced device developers, or ongoing advising that continues beyond the short course itself.

From an eligibility standpoint, NIH opened the competition to a wide range of U.S.-based organizations, reflecting the educational and workforce-development aim. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (as long as they otherwise meet NIH eligibility rules); for-profit organizations other than small businesses; and small businesses. It also explicitly highlights participation by a range of institution types that often serve diverse or underserved communities, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies. U.S. territories or possessions and regional organizations are also listed as eligible.

At the same time, there are important geographic and organizational restrictions. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a primarily U.S.-based applicant could include certain foreign collaborations or elements if they meet NIH policy requirements and are well-justified within the project structure.

The opportunity is categorized as a discretionary grant under an education-focused activity category, and it is explicitly labeled “Clinical Trial Not Allowed,” meaning the supported activities must remain in the training and educational domain rather than testing an intervention in human participants as a clinical trial. The award ceiling is listed as $250,000. The original closing date for the solicitation was December 16, 2019, and the opportunity was created on September 20, 2019. It is associated with multiple CFDA numbers (now generally referenced under Assistance Listings), reflecting its placement within NIH and Blueprint-related funding structures that span several participating institutes and centers.

Overall, this FOA is best understood as NIH Blueprint’s effort to professionalize and standardize translational device education in neuroscience by funding organizations to build a high-impact short course that demystifies device translation, teaches realistic roadmapping and de-risking, and connects participants to the practical tools and resources they need to move from academic insight or early prototype toward a viable medical device pathway.

• The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "NIH Blueprint for Neuroscience Research Education Program on Translational Devices (R25 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.213, 93.242, 93.273, 93.279, 93.286, 93.361, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2019-09-20.
• Applicants must submit their applications by 2019-12-16. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $250,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA NS 20 003

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: