Opportunity Information: Apply for RFA NS 21 022
The Translational Neural Devices (U44 Clinical Trial Optional) funding opportunity (RFA-NS-21-022) is a National Institutes of Health (NIH) cooperative agreement designed to help small businesses move promising neural and neuromuscular device concepts closer to real-world patient use. It focuses specifically on therapeutic and diagnostic devices aimed at disorders that affect the nervous system or neuromuscular systems, with an emphasis on practical, development-focused work that bridges the gap between early prototypes and readiness for regulated clinical testing and, ultimately, commercialization. The award uses the U44 mechanism, which is structured to support later-stage translational development and can include a clinical component, but does not require a clinical trial in every project, hence the "clinical trial optional" designation.
The core goal is to support translational activities that de-risk and mature a device so it is ready for a formal regulatory pathway into human studies. Supported development work can include translational bench testing and animal studies that generate the performance and safety evidence needed for regulatory submissions. The FOA explicitly anticipates that these preclinical and engineering activities will lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA), or alternatively an Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study when the device and proposed study qualify under that framework. In other words, the program is structured around the expectation that awardees will produce the kind of data package and documentation that regulators and ethics oversight bodies require before a device can be evaluated in people.
In addition to preclinical and translational development, the cooperative agreement can also support a subsequent small clinical study. The intent of that clinical work is to collect early safety and effectiveness information that is directly relevant to moving toward a marketing application (for example, supporting a future FDA submission) or to inform final device design decisions before larger or more definitive trials. These studies are described as "small" and are positioned as a targeted step to gather key human data that answers specific questions about device performance, usability, safety profile, and early signals of benefit, rather than serving as a full-scale pivotal trial by default.
This opportunity is aimed at Small Business Concerns (SBCs) as the eligible applicant category. It is listed as a discretionary funding opportunity, and the funding instrument is a cooperative agreement, which typically means NIH staff are expected to have substantial programmatic involvement compared with a standard grant. The NIH activity area is health, and the listing is associated with CFDA number 93.853. The publicly provided award ceiling is $1,000,000, indicating the program is meant to fund meaningful late-stage development tasks and a limited clinical effort, though actual budgets generally need to align with the specific scope and milestones proposed.
Eligibility is restricted in ways that matter for companies with international ties. Non-domestic (non-U.S.) entities, including foreign institutions, are not eligible to apply. Non-domestic components of U.S. organizations are also not eligible to apply, which limits the ability to place major parts of the work outside the United States under the applicant organization. However, "foreign components" as defined in the NIH Grants Policy Statement may be allowed, meaning some specific, justified elements of work could potentially involve foreign participation under NIH rules, but the applicant itself must be an eligible U.S. small business and the overall structure must comply with NIH policy. The opportunity was created on April 28, 2021, and the original closing date listed is December 20, 2022.
Overall, the FOA is best understood as a targeted push to help small businesses turn neural device innovations into regulated, clinically testable products by funding the practical steps that often stall development: rigorous bench validation, relevant animal studies, design refinement, and the preparation of IDE or NSR materials, with optional support for a focused early clinical study that generates the initial human data needed for the next regulatory and commercial decisions.Apply for RFA NS 21 022
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Translational Neural Devices (U44 Clinical Trial Optional)" 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 2021-04-28.
- Applicants must submit their applications by 2022-12-20. (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.
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Frequently Asked Questions (FAQs): Translational Neural Devices (U44 Clinical Trial Optional) - RFA-NS-21-022
What is the Translational Neural Devices (U44 Clinical Trial Optional) funding opportunity?
It is a National Institutes of Health (NIH) cooperative agreement funding opportunity (RFA-NS-21-022) intended to help small businesses advance promising neural and neuromuscular device concepts toward real-world patient use. The program emphasizes practical, development-focused work that bridges the gap between early prototypes and readiness for regulated clinical testing and, ultimately, commercialization.
What types of devices are the focus of this opportunity?
The opportunity focuses on therapeutic and diagnostic devices aimed at disorders that affect the nervous system or neuromuscular systems. The intent is to support technologies that can realistically be matured into clinically testable and commercially viable medical devices.
What does "translational" mean in the context of this FOA?
Here, "translational" refers to the development work needed to move a device from an early concept or prototype into a more mature, de-risked product that is ready to enter a formal regulatory pathway toward human testing. This includes generating the kinds of performance and safety evidence regulators and oversight bodies expect before a device can be evaluated in people.
What is the funding mechanism used for this program?
The funding instrument is a cooperative agreement using the U44 mechanism. A cooperative agreement typically involves substantial NIH staff programmatic involvement compared with a standard grant mechanism.
What does "Clinical Trial Optional" mean?
"Clinical Trial Optional" means a clinical trial is not required for every project. A project may focus on preclinical and engineering work to prepare for regulated human testing, and the FOA also allows (but does not require) inclusion of a subsequent small clinical study when appropriate.
What is the core goal of the award?
The core goal is to support activities that de-risk and mature a neural or neuromuscular device so it is ready for a formal regulatory pathway into human studies. The program is structured around building the evidence and documentation needed to proceed responsibly and compliantly into clinical evaluation.
What types of development activities are supported?
Supported work can include translational bench testing and animal studies designed to generate performance and safety evidence needed for regulatory submissions. The emphasis is on practical steps that often stall development, such as rigorous validation, relevant preclinical studies, and design refinement.
Is the program geared toward regulatory readiness?
Yes. The FOA explicitly anticipates that preclinical and engineering activities will lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA), or alternatively an Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study when appropriate.
What is an IDE in the context described here?
In this FOA, an IDE submission is described as a likely regulatory outcome of the supported translational work, meaning awardees are expected to generate a data package and documentation that can support an FDA pathway to evaluate the device in human studies.
What is an IRB NSR application and when is it relevant?
The FOA notes an alternative pathway: an IRB application for a Non-Significant Risk (NSR) study, when the device and proposed study qualify under that framework. This indicates that some projects may be positioned to pursue human research oversight through IRB review under NSR criteria rather than an IDE, depending on the risk profile and study design.
Can this award support clinical research in humans?
Yes, the cooperative agreement can support a subsequent small clinical study. The clinical component is intended to collect early safety and effectiveness information that is directly relevant to moving toward a marketing application (for example, supporting a future FDA submission) or to inform final device design decisions before larger trials.
What is the intended scale and purpose of the clinical study component?
The FOA describes these as "small" studies. They are positioned as a targeted step to gather key human data about device performance, usability, safety profile, and early signals of benefit. They are not presented as default full-scale pivotal trials.
Who is eligible to apply?
The eligible applicant category is Small Business Concerns (SBCs). The program is designed specifically to help small businesses translate device innovations toward clinical testing and commercialization.
Are non-U.S. (foreign) entities eligible to apply?
No. Non-domestic (non-U.S.) entities, including foreign institutions, are not eligible to apply under this opportunity.
Can a U.S. small business apply if it plans to conduct part of the work outside the United States?
There are restrictions. Non-domestic components of U.S. organizations are not eligible to apply, which limits placing major parts of the work outside the United States under the applicant organization. However, "foreign components" as defined in the NIH Grants Policy Statement may be allowed when justified and structured to comply with NIH policy, while the applicant remains an eligible U.S. small business.
What is meant by a "foreign component" being allowed?
The FOA indicates that certain specific, justified elements of work could potentially involve foreign participation under NIH rules (as defined in the NIH Grants Policy Statement). This does not change the requirement that the applicant must be an eligible U.S. small business and that non-domestic entities are not eligible to apply.
What is the award ceiling for this opportunity?
The publicly provided award ceiling is $1,000,000. This suggests the program is intended to fund meaningful late-stage development tasks and potentially a limited clinical effort, with budgets expected to align with the proposed scope and milestones.
What is the CFDA number associated with this listing?
The listing is associated with CFDA number 93.853.
What is the NIH activity area for this opportunity?
The NIH activity area listed for this funding opportunity is health.
What does it mean that this is a discretionary funding opportunity?
It is listed as a discretionary funding opportunity, meaning it is not an entitlement program and funding decisions are made through a competitive process consistent with the program's goals and requirements.
When was this opportunity created and what is the closing date listed?
The opportunity was created on April 28, 2021, and the original closing date listed is December 20, 2022.
What is the overall intent of the program in plain terms?
The program is a targeted push to help small businesses turn neural device innovations into regulated, clinically testable products. It funds the practical steps needed to move from promising prototypes to regulatory readiness, including bench validation, animal studies, design refinement, and preparation of IDE or NSR materials, with optional support for an early, focused clinical study.
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