Translational Neural Devices (U44 - Clinical Trial Required) | RFA NS 18 012

Opportunity Information: Apply for RFA NS 18 012

The Translational Neural Devices (U44 - Clinical Trial Required) funding opportunity (RFA-NS-18-012) is a National Institutes of Health (NIH) cooperative agreement designed to help small businesses move promising neural and neuromuscular device concepts toward real-world clinical use. The core focus is on therapeutic and diagnostic devices intended to address disorders of the nervous system or neuromuscular systems, with an emphasis on practical, development-stage work that bridges the gap between early prototype research and the evidence needed for commercialization or broader clinical adoption.

This FOA supports a structured, translational pathway that starts with late-stage preclinical and engineering work and continues through a small clinical study. On the preclinical side, applicants are expected to carry out targeted translational activities such as bench testing, design refinement, verification and validation work, and animal studies when appropriate. These activities are not meant to be exploratory science; they are meant to reduce regulatory and technical risk and to generate the specific data package needed to move into human testing. A key milestone is preparing for and submitting either an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for studies that require it, or an Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) device study when that regulatory pathway applies. In other words, the program expects teams to be working toward a clear regulatory plan and to produce the evidence that supports that plan.

Beyond translational development, the award also funds a subsequent small clinical study. The purpose of that clinical component is to collect initial safety and effectiveness data that can support a future marketing application (depending on device type and regulatory pathway, this could contribute to a 510(k), De Novo, or PMA strategy) or, at minimum, inform final device design decisions before larger trials or broader deployment. The clinical study is described as "small," which typically signals an early, focused human evaluation rather than a large pivotal trial, with endpoints and design choices aligned to what is realistic and decision-enabling at this stage of development.

Because this is a cooperative agreement (U44), recipients should expect substantial programmatic involvement from NIH compared with a standard grant. In practice, that usually means closer coordination, milestone-driven progress expectations, and active communication around regulatory, technical, and clinical execution to keep the project aligned with the translational intent of the program. The activity category is Health, and the listing is associated with CFDA number 93.853.

Eligibility is limited to U.S. small businesses (Small Business Concerns). Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible as applicant components. However, "foreign components" as defined by the NIH Grants Policy Statement may be allowable in some cases, meaning certain discrete project elements could potentially be performed outside the U.S. if justified and permitted under NIH policy, but the applicant organization itself must be an eligible U.S. small business and the overall project must comply with the FOA's restrictions.

Key administrative details from the posting include an award ceiling of $1,000,000 and an original closing date of February 22, 2021, with the opportunity created on November 8, 2017. Overall, the program is aimed at helping small companies de-risk neural and neuromuscular device development, align with FDA/IRB requirements, and produce early human data that supports either a marketing submission or the final engineering and clinical decisions needed before scaling up.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Translational Neural Devices (U44 - Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2017-11-08.
• Applicants must submit their applications by 2021-02-22. (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 $1,000,000.00 in funding.
• Eligible applicants include: Small businesses.

Apply for RFA NS 18 012

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