Opportunity Information: Apply for PAR 14 296
Apply for PAR 14 296
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS CREATE Devices Translational and Clinical Studies on the Path to 510(k) (U44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Jul 28, 2014 and posted on Jul 28, 2014.
- Applicants must submit their applications by May 7, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
- Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture 3. (i) SBIR and STTR. Be a concern which is more than 50 directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these OR (ii) SBIR only. Be a concern which is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 of the concern OR (iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements. 4. Has, including its affiliates, not more than 500 employees.
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Opportunity Summary:
The NINDS CREATE Devices Translational and Clinical Studies on the Path to 510(k) (U44) opportunity (Funding Opportunity Number PAR 14 296) is an NIH program designed to help small businesses move therapeutic neurological devices out of earlier development and into the kinds of translational and early clinical work needed to reach a near-term FDA marketing pathway. The central goal is practical: generate the data, prototypes, verification/validation work, and regulatory clearances needed to run a focused clinical study, with the expectation that the project is positioned so the next step after that study is either an FDA 510(k) or 510(k) De Novo submission, or a larger clinical trial that very directly leads into one of those submissions. In other words, it targets the stretch of work where a device is no longer just a concept or benchtop prototype, but not yet sufficiently proven and documented to support a clearance submission, and it funds the structured steps to close that gap.
This FOA uses a cooperative agreement funding instrument, specifically a U44, which signals that the project is not funded as a hands-off research grant. Under a cooperative agreement, NIH (here, the National Institute of Neurological Disorders and Stroke, NINDS) typically has more substantial programmatic involvement than under standard grants, with milestone-driven oversight and coordination intended to keep the project aligned with the regulatory and translational objectives. The funding activity sits within NIH’s health research domain, under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), and it is explicitly aimed at therapeutic devices for neurological disorders rather than basic science or purely exploratory device concepts.
The work supported is the set of activities that usually determines whether a device program can credibly enter human testing and then credibly claim readiness for FDA review. That includes building and implementing a clinical prototype device (the version suitable for use in a clinical setting, not just an engineering prototype), conducting preclinical safety and efficacy testing appropriate to the technology and intended use, and completing design verification and validation activities. It also includes the regulatory steps required to legally start the clinical study, specifically preparing and submitting an Investigational Device Exemption (IDE) when the study is significant risk, or securing IRB approval for a Non Significant Risk (NSR) study when IDE submission is not required. The FOA then supports the conduct of a small clinical study, meaning a limited, well-defined human study intended to answer key questions that de-risk the device and support the anticipated 510(k) or De Novo pathway, rather than a large pivotal trial by default.
A defining feature of the program is its “path to 510(k)” framing. A traditional 510(k) submission is built around demonstrating substantial equivalence to a legally marketed predicate device, while a 510(k) De Novo pathway is used when there is no suitable predicate but the risk profile supports a Class I or II classification with appropriate controls. This FOA is built for projects where the commercialization and regulatory plan is already oriented toward one of those routes, and where the proposed preclinical and clinical package is intentionally designed to produce the kind of documentation and evidence that will be directly usable in an FDA submission, rather than generic academic outputs. The expectation that the immediate next steps after the funded clinical study are a 510(k)/De Novo submission or a larger study tightly linked to such a submission is essentially a readiness requirement: applicants are meant to be beyond early feasibility brainstorming and closer to a real-world regulatory trajectory.
Eligibility is limited to United States small business concerns (SBCs), reflecting its SBIR-style focus on commercialization-oriented development. To qualify, the applicant organization must be for-profit, have a place of business in the United States, and operate primarily in the United States or make a significant contribution to the U.S. economy through taxes or the use of American products, materials, or labor. The entity must fit an allowable legal structure (such as an individual proprietorship, partnership, LLC, corporation, joint venture, association, trust, cooperative), and if it is a joint venture there must be less than 50 percent participation by foreign business entities. The small business must also meet ownership and control requirements tied to SBIR/STTR rules (including allowable structures involving majority ownership by U.S. citizens or permanent residents, or in SBIR-only cases, certain venture-backed ownership structures with limits so that no single VC, hedge fund, or private equity firm owns more than 50 percent). Finally, the company (including affiliates) must have no more than 500 employees. There is no cost sharing or matching requirement stated for this opportunity, which matters for small businesses budgeting a development program.
From an administrative standpoint, the FOA was posted July 28, 2014, with an original and final closing date of May 7, 2017, and it was archived June 7, 2017. That means it is not currently open for new applications, but it remains a useful reference point for understanding how NINDS has structured support for device translation and early clinical validation, especially for teams aiming at 510(k) or De Novo clearance strategies. The full announcement was hosted through NIH Grants policy/announcement pages (the link provided in the source points to the archived FOA), and NIH listed the Office of Extramural Research (OER) webmaster contacts for technical access issues.
In practical terms, the opportunity was built for a small business that already has a clear therapeutic device concept for a neurological disorder and needs support to (1) finalize a clinically usable prototype, (2) generate the preclinical and design control evidence that FDA and IRBs expect, (3) secure IDE approval or document NSR status and obtain IRB approval, and (4) run a limited clinical study that meaningfully positions the device for a near-term FDA clearance submission. The emphasis is on translational execution and regulatory readiness rather than open-ended research, with NIH actively engaged through the cooperative agreement structure to keep the project moving toward the 510(k)/De Novo end point.
FAQs: NINDS CREATE Devices Translational and Clinical Studies on the Path to 510(k) (U44) - PAR 14 296
What is the NINDS CREATE Devices "Path to 510(k)" (U44) opportunity?
It is an NIH program from the National Institute of Neurological Disorders and Stroke (NINDS) designed to help U.S. small businesses move therapeutic neurological devices beyond early development and into translational and early clinical work that supports a near-term FDA marketing pathway. The intent is to fund the specific steps needed to reach a point where the next logical move is an FDA 510(k) or 510(k) De Novo submission, or a larger clinical trial that very directly leads into one of those submissions.
What is the central goal of this funding opportunity?
The central goal is practical and regulatory-focused: generate the data, clinical prototypes, verification/validation work, and regulatory clearances needed to run a focused clinical study, with the expectation that the project is positioned so the next step after the study is either an FDA 510(k) submission, a 510(k) De Novo submission, or a larger clinical study that directly supports one of those submissions.
What stage of device development is this program meant for?
It targets the in-between stage where a device is beyond a concept or benchtop prototype, but not yet sufficiently proven and documented to credibly support an FDA clearance submission. The program funds structured activities meant to close that gap and prepare for a near-term regulatory pathway.
What types of devices does the opportunity focus on?
It is explicitly aimed at therapeutic devices for neurological disorders. It is not described as a program for basic science or purely exploratory device concepts.
What does "on the path to 510(k)" mean in this FOA?
It means the commercialization and regulatory plan is expected to be oriented toward FDA clearance through either (1) a traditional 510(k) pathway, which involves demonstrating substantial equivalence to a legally marketed predicate device, or (2) a 510(k) De Novo pathway, used when there is no suitable predicate but the risk profile supports Class I or II classification with appropriate controls.
What is the expected outcome after the funded clinical study?
The expectation is that the immediate next step after the funded clinical study is either an FDA 510(k)/De Novo submission, or a larger clinical trial that is tightly linked to and directly leads into one of those submissions. This functions as a readiness requirement: the project should be close to a real-world regulatory trajectory rather than early feasibility brainstorming.
What funding instrument is used and why does it matter?
The FOA uses a cooperative agreement funding instrument (U44). This signals more substantial NIH programmatic involvement than a standard research grant, with milestone-driven oversight and coordination intended to keep the project aligned with translational and regulatory objectives.
What kinds of activities are supported under this opportunity?
The supported work includes activities that typically determine whether a device program can credibly enter human testing and be ready for FDA review. Examples specifically described include: building and implementing a clinical prototype device; conducting preclinical safety and efficacy testing appropriate to the technology and intended use; completing design verification and validation activities; preparing and submitting an Investigational Device Exemption (IDE) when the study is significant risk; securing IRB approval for a Non Significant Risk (NSR) study when an IDE submission is not required; and conducting a small, well-defined clinical study designed to de-risk the device and support the anticipated 510(k) or De Novo pathway.
What is meant by a "clinical prototype" in this program?
The FOA distinguishes a clinical prototype from an engineering prototype. A clinical prototype is the version suitable for use in a clinical setting, not merely a benchtop or engineering-only prototype.
Does the program support preclinical work?
Yes. It supports preclinical safety and efficacy testing appropriate to the technology and intended use, along with related development work such as design verification and validation.
Does the program support regulatory steps like IDE or IRB activities?
Yes. The FOA specifically includes regulatory steps required to legally start the clinical study. That includes preparing and submitting an IDE when the study is significant risk, or securing IRB approval for an NSR study when an IDE submission is not required.
Does this opportunity fund large pivotal clinical trials?
The FOA describes support for a small clinical study, defined as a limited, well-defined human study intended to answer key questions that de-risk the device and support the anticipated 510(k) or De Novo pathway, rather than defaulting to a large pivotal trial.
Who is eligible to apply?
Eligibility is limited to United States small business concerns (SBCs). The applicant must be for-profit, have a place of business in the United States, and operate primarily in the United States or make a significant contribution to the U.S. economy through taxes or the use of American products, materials, or labor.
What legal entity types can qualify as a small business concern for this FOA?
The FOA notes allowable legal structures such as an individual proprietorship, partnership, LLC, corporation, joint venture, association, trust, cooperative, and other qualifying forms consistent with SBIR-style rules described in the opportunity.
Are there restrictions related to foreign ownership or foreign participation?
Yes. For joint ventures, the FOA specifies that there must be less than 50 percent participation by foreign business entities.
Are there specific SBIR/STTR-style ownership and control requirements?
Yes. The opportunity references SBIR/STTR-related ownership and control rules, including allowable structures involving majority ownership by U.S. citizens or permanent residents and, in SBIR-only cases described, certain venture-backed ownership structures with limits so that no single venture capital (VC), hedge fund, or private equity firm owns more than 50 percent.
Is there an employee headcount limit?
Yes. The company, including affiliates, must have no more than 500 employees.
Is cost sharing or matching required?
No cost sharing or matching requirement is stated for this opportunity, based on the information provided.
What NIH area and CFDA listing is this program associated with?
The funding activity is within NIH's health research domain and is listed under CFDA 93.853, Extramural Research Programs in the Neurosciences and Neurological Disorders.
Is this funding opportunity currently open?
No. The FOA was posted July 28, 2014, had an original and final closing date of May 7, 2017, and was archived June 7, 2017. Based on those dates, it is not currently open for new applications.
Where was the original announcement hosted and who was listed for technical access issues?
The full announcement was hosted through NIH Grants policy/announcement pages as an archived FOA. NIH listed Office of Extramural Research (OER) webmaster contacts for technical access issues.
What kind of applicant is this program best suited for (in practical terms)?
It was built for a U.S. small business that already has a clear therapeutic device concept for a neurological disorder and needs support to finalize a clinically usable prototype, generate the preclinical and design control evidence expected by FDA and IRBs, secure IDE approval or document NSR status and obtain IRB approval, and run a limited clinical study that positions the device for a near-term FDA clearance submission.
What makes this program different from open-ended academic research support?
The emphasis is on translational execution and regulatory readiness rather than generic academic outputs. The cooperative agreement structure also indicates active NIH engagement and milestone-driven oversight to keep the project aligned with the 510(k)/De Novo end point.
Browse more opportunities from the same category: Health
Next opportunity: NINDS CREATE Devices Translational and Clinical Studies to Inform Final Device Design (UH2/UH3)
Previous opportunity: NINDS CREATE Devices Translational and Clinical Studies on the Path to 510(k) (UH2/UH3)
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