BRAIN Initiative Next Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH2/UH3) | Apply Online

Opportunity Summary:

The BRAIN Initiative Next Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH2/UH3) opportunity (Funding Opportunity Number RFA-NS-15-006) is a National Institutes of Health (NIH) cooperative agreement program aimed at pushing promising invasive neural interface technologies out of the lab and into early human testing. The core goal is to support translational and clinical work on devices that can record from and/or stimulate the human central nervous system, with the long-term intent of improving treatment options for nervous system disorders while also advancing scientific understanding of how the human brain functions. This is not a basic research device development call; it is structured to help teams do the practical, regulated work needed to reach a first-in-human or similarly early clinical evaluation when additional bench or animal studies cannot realistically answer the remaining key questions because the device or intended use is novel.

A central feature of the program is its two-phase UH2/UH3 structure paired with the cooperative agreement mechanism, meaning NIH staff are expected to be actively involved through milestones, coordination, and oversight rather than acting purely as a passive funder. The program is designed to move projects through a well-defined translational path: first, preparing for and securing the right approvals to study the device in people, and second, carrying out a small, tightly scoped clinical study. On the regulatory side, the FOA explicitly anticipates supporting either (1) submission of an Investigational Device Exemption (IDE) to the FDA for a Significant Risk (SR) study, or (2) obtaining Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, depending on how the device and protocol are classified. The clinical work envisioned is typically an Early Feasibility Study or another small clinical study intended to generate focused, decision-enabling data rather than large-scale efficacy evidence.

The small clinical study is expected to answer key questions about either how the device performs in humans or what the final device design should be. In practical terms, the trial should generate information that materially guides the device toward a final clinical prototype or design freeze, such as confirming functional performance in the intended anatomical setting, validating stimulation or recording characteristics in real-world use, clarifying usability and workflow constraints in a surgical or inpatient environment, or identifying critical design changes needed before larger clinical trials and eventual market authorization. The FOA emphasizes that this human study should provide information that cannot be practically obtained through additional nonclinical testing alone (for example, when bench testing and animal models do not adequately replicate the relevant human neuroanatomy, tissue-device interactions, signal environment, or clinical workflow). The end result is expected to be a device design that may have completed most, if not all, of the nonclinical testing required to move into more advanced clinical trials and, ultimately, a potential pathway toward commercialization and broader clinical adoption.

In terms of supported activities, the FOA covers the major building blocks of translational device readiness. This includes implementation of clinical prototype devices (meaning the device is mature enough to be built and used under clinical conditions), nonclinical safety and efficacy testing (as appropriate for the device and intended use), and design verification and validation work. It also explicitly supports the work required to pursue regulatory approval for the clinical investigation and to actually run one small clinical study. Taken together, these components reflect an emphasis on engineering rigor and regulatory-grade evidence generation: ensuring the device is manufactured and tested in a way that supports an IDE or NSR determination, demonstrating that it meets design requirements, and generating early human data that reduces uncertainty about performance and safety in the intended context of use.

The opportunity is categorized as discretionary funding and uses a cooperative agreement funding instrument, reflecting the expectation of substantial NIH involvement. The estimated total funding amount listed for the announcement is $9,000,000. It was posted and created on February 3, 2015, with an original and current closing date of April 14, 2015, and an archive date of May 15, 2015. While the dates indicate this specific FOA round is historical, the summary is still useful as a model of how NIH has structured BRAIN Initiative translational neurotechnology programs, particularly those bridging invasive device development and early clinical validation.

Eligibility is broad across U.S.-based organizations and government entities, including public and private institutions of higher education, nonprofits (including 501(c)(3) organizations), for-profit organizations (including small businesses and for-profits other than small businesses), and a wide range of local, state, tribal, and regional governmental bodies (such as city or township governments, county governments, special district governments, and public housing authorities/Indian housing authorities). The FOA also highlights eligibility for multiple institution types serving specific communities, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), as well as faith-based or community-based organizations and eligible federal agencies. At the same time, it clearly restricts foreign participation: non-U.S. entities (foreign institutions) cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed.

The FOA is associated with multiple NIH-related CFDA numbers spanning neuroscience, mental health, addiction, aging, vision, child health and human development, and technology innovation areas, reflecting how invasive recording and stimulation platforms can cut across many disease and research domains. The official funding announcement link is listed as http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-15-006.html, and contact support referenced in the posting directs technical access and linking issues to the NIH Office of Extramural Research (OER) webmaster email. Overall, the opportunity is best understood as a translational bridge program: it funds the engineering, testing, regulatory, and early clinical steps necessary to prove whether a next-generation invasive neural device is ready to advance beyond the prototype stage and into more definitive clinical development.

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