NINDS CREATE Devices Translational and Clinical Studies to Inform Final Device Design (UH2/UH3) | Apply Online

Opportunity Summary:

The NINDS CREATE Devices Translational and Clinical Studies to Inform Final Device Design (UH2/UH3) funding opportunity (PAR-14-297) was a National Institutes of Health program designed to push promising therapeutic device concepts for neurological disorders through the late translational steps needed to reach an early clinical study and, just as importantly, to use that study to lock in a final device design. The basic idea is that many neurotherapeutic devices stall between the laboratory prototype stage and the point where there is enough human data and design maturity to justify larger, more definitive clinical trials and eventual marketing pathways. This FOA targeted that gap by supporting the engineering, testing, regulatory work, and small-scale clinical evaluation needed to produce a design that is ready to proceed through the remaining preclinical and clinical milestones toward broader clinical use.

A key feature of the program is its use of a cooperative agreement mechanism (UH2/UH3), which generally implies substantial NIH involvement compared to a standard research grant. In practical terms, this structure supports a staged project: an initial phase focused on completing the critical preparatory work (often including finalizing a clinical-grade prototype, finishing required bench and animal testing, and preparing for regulatory and ethics review), followed by a subsequent phase that conducts a small clinical study. The intended progression is to enable either submission of an Investigational Device Exemption (IDE) to the FDA for significant risk device studies or, when appropriate, to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and then to carry out the human study under that regulatory/ethical framework.

The FOA emphasizes that the supported clinical work is not meant to be a large pivotal trial. Instead, it is meant to be a focused, early clinical study that generates the specific evidence needed to inform and finalize the device design. That can include feasibility, usability, initial safety signals, procedural refinements, parameter optimization, or performance characteristics that cannot be reliably resolved without human use. The expectation is that, after this study, the device design should be sufficiently settled that it would then undergo most, if not all, of the preclinical testing typically required for more advanced clinical trials and eventual market approval, rather than continuing to change in ways that would force repeated re-testing.

Another important purpose is enabling devices that allow investigators to test scientific hypotheses that are difficult or impractical to study in animal models but are essential for the next generation of neurodevices. In other words, the program is not only about incremental translation of an existing device concept; it also supports creation of clinical-capable tools when human-specific physiology, circuit behavior, or disease characteristics must be studied directly to drive meaningful innovation.

The types of activities explicitly supported span the full translational workflow for devices approaching first-in-human or early feasibility clinical use. This includes implementing clinical prototype devices (bringing prototypes to a form suitable for controlled clinical investigation), conducting preclinical safety and efficacy testing as needed to justify human exposure, and completing design verification and validation work that demonstrates the device meets its specifications and intended performance requirements. It also includes the regulatory steps required to start the study (IDE preparation/submission when applicable, or NSR determinations and IRB approvals) and then executing a small clinical study that produces actionable data to guide final design decisions.

Eligibility was broad across U.S.-based organizations and government entities, reflecting the multidisciplinary and cross-sector nature of device development. Eligible applicants included state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), small businesses, and other for-profit organizations. The announcement also listed categories such as HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, faith-based and community-based organizations, and eligible federal agencies. At the same time, it clearly restricted non-U.S. participation in key ways: non-domestic (non-U.S.) entities were not eligible to apply, non-domestic components of U.S. organizations were not eligible, and foreign components (as defined by NIH policy) were not allowed. There was no cost sharing or matching requirement, reducing barriers for applicants who may not have large pools of discretionary capital for late-stage development work.

Administratively, this opportunity was categorized as a discretionary, extramural NIH program under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). It was posted July 28, 2014, with a closing date of May 7, 2017, and an archive date of June 7, 2017, meaning it is no longer open under that specific solicitation. The sponsoring agency was NIH (with NINDS as the institute associated with the CREATE Devices program). The full archived announcement was available via the NIH Grants Guide at the provided link (http://grants.nih.gov/grants/guide/pa-files/PAR-14-297.html), and NIH’s Office of Extramural Research webmaster contact was listed for access or linking issues.

Overall, the program can be thought of as a bridge between promising neurotherapeutic device prototypes and the point where a device has enough design stability, verification/validation evidence, regulatory clearance to study in humans, and targeted early clinical data to justify the next costly steps: broader preclinical packages (as needed for the finalized configuration), more advanced clinical trials, and ultimately a credible path to market authorization.

Browse more opportunities from the same agency: National Institutes of Health

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Next opportunity: NINDS CREATE Devices Translational and Early Feasibility Studies on the Path to Pre Market Approval (PMA) or Humanitarian Device Exemption (HDE) (UH2/UH3)

Previous opportunity: NINDS CREATE Devices Translational and Clinical Studies on the Path to 510(k) (U44)

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