Opportunity Information: Apply for PAR 14 299
Apply for PAR 14 299
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS CREATE Devices Translational and Early Feasibility Studies on the Path to Pre Market Approval (PMA) or Humanitarian Device Exemption (HDE) (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 Early Feasibility Studies program (PAR-14-299) is a National Institutes of Health funding opportunity designed to move therapeutic device concepts for neurological disorders out of the lab and into the clinic on a credible regulatory path toward U.S. market authorization. The focus is on the practical, late-stage translation work that must happen before a device can be tested in people under an Investigational Device Exemption (IDE), and, if appropriate, on conducting an Early Feasibility Study immediately after the IDE is in place. The larger aim is to position a device so that, once this project is complete, the logical next steps are a larger feasibility study and then a pivotal trial intended to support either a Pre-Market Approval (PMA) application or a Humanitarian Device Exemption (HDE), depending on the intended population and regulatory strategy.
This opportunity uses a cooperative agreement mechanism (U44), which generally means NIH staff are expected to have substantial involvement during the project rather than acting only as a passive funder. In practice, that structure is meant to help teams stay aligned with the technical, clinical, and regulatory milestones needed for an IDE submission and early-in-human testing. The program is centered on therapeutic devices for neurological disorders, and it is specifically aimed at the translational gap where many device projects stall: converting a promising prototype into a clinically usable “clinical prototype†with evidence of safety and performance, appropriate documentation, and a regulatory plan that can withstand FDA review.
The activities supported are the ones that directly de-risk a device for early clinical use and make an IDE package realistic. That includes building and implementing a clinical prototype device (not just a benchtop proof-of-concept), running preclinical safety and efficacy testing appropriate for the technology and intended use, and completing design verification and validation work to show the device meets its specifications and performs as intended. It also includes preparing for and pursuing regulatory authorization to run the clinical study, culminating in submission of an IDE. After the IDE, the award can also support the initial Early Feasibility Study, which is typically a small, carefully monitored first-in-human study designed to evaluate basic safety, device function in the clinical environment, procedural workflow, and early signals of potential benefit, while generating the information needed to refine the device and plan subsequent trials.
Eligibility is limited to U.S. small business concerns, reflecting the program’s goal of advancing commercializable products. To qualify, an applicant must be organized for profit, have a place of business in the United States, and operate primarily in the U.S. (or otherwise make a significant contribution to the U.S. economy through taxes or the use of American labor or materials). The business must fit within specific ownership and control rules applicable to SBIR/STTR-style small business eligibility, including certain pathways that allow majority ownership by U.S. individuals or, in some cases, by multiple venture capital operating companies, hedge funds, or private equity firms as long as no single such entity owns more than 50%. The company (including affiliates) must have no more than 500 employees. No cost sharing or matching is required under this opportunity, which can lower the barrier for small companies that are still assembling financing for a longer clinical and regulatory runway.
Administratively, the FOA is classified as discretionary funding using the “Health†activity category and is associated with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). It was posted on July 28, 2014, and the final closing date listed for applications was May 7, 2017, with the archive date of June 7, 2017, meaning it is not an open, active competition today but remains relevant as a reference for the CREATE Devices program structure and expectations. The sponsoring agency is the National Institutes of Health, specifically through NINDS, and the full announcement was hosted on the NIH grants guide site.
Overall, this funding opportunity is best understood as support for the last major preclinical and engineering steps plus the regulatory and clinical launch activities needed to start human testing of a neurological therapeutic device. Rather than funding basic discovery or long exploratory research, it emphasizes deliverables that regulators and clinical trial planners care about: a device built to a clinical standard, evidence supporting reasonable safety for initial use, documentation of verification and validation, an IDE submission, and an early feasibility clinical dataset that sets up the next stages (feasibility and pivotal trials) required for PMA or HDE pathways.
FAQs: NINDS CREATE Devices Translational and Early Feasibility Studies (PAR-14-299)
What is the NINDS CREATE Devices Translational and Early Feasibility Studies program (PAR-14-299)?
It is a National Institutes of Health (NIH) funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) intended to move therapeutic device concepts for neurological disorders out of the lab and toward clinical testing in humans on a credible U.S. regulatory path.
What is the main goal of this funding opportunity?
The goal is to support the late-stage translational work needed to make an Investigational Device Exemption (IDE) submission realistic and, when appropriate, to support an Early Feasibility Study after the IDE is in place. The larger intent is to position the device so the next steps after this project are a larger feasibility study and then a pivotal trial aimed at supporting a Pre-Market Approval (PMA) application or a Humanitarian Device Exemption (HDE).
What kinds of projects are a fit for this program?
Projects focused on therapeutic devices for neurological disorders that are beyond basic discovery and need practical translation work to reach early-in-human testing. The program targets the common gap where device projects stall: converting a promising prototype into a clinically usable device with evidence of safety and performance, appropriate documentation, and an FDA-ready regulatory plan.
Does this program fund basic research or early discovery?
No. The emphasis is not on basic discovery or long exploratory research. It focuses on deliverables required for early clinical use and regulatory review, such as a clinical prototype, verification and validation, appropriate preclinical testing, and an IDE submission, with potential support for an Early Feasibility Study.
What stage of device development does this program focus on?
It focuses on late-stage translation: the major preclinical and engineering steps plus regulatory preparation needed before a device can be tested in people under an IDE, and potentially the initial early feasibility clinical work immediately after the IDE is granted/active.
What is meant by moving a device onto a "credible regulatory path" toward U.S. market authorization?
It means generating the testing, documentation, and evidence that support FDA review for early human use (IDE), and setting up the device development program so that subsequent studies can support a marketing submission such as PMA or HDE, depending on the regulatory strategy and intended population.
What is the funding mechanism used for this opportunity?
The opportunity uses a cooperative agreement mechanism (U44).
What does a cooperative agreement (U44) imply about NIH involvement?
A U44 generally means NIH staff are expected to have substantial involvement during the project rather than acting only as a passive funder. In practice, this structure is intended to help project teams stay aligned with technical, clinical, and regulatory milestones needed for an IDE submission and early-in-human testing.
What are the core activities supported before an IDE is in place?
Supported activities include building and implementing a clinical prototype device (not merely a benchtop proof-of-concept), conducting appropriate preclinical safety and efficacy testing for the technology and intended use, and completing design verification and validation to show the device meets specifications and performs as intended. The program also supports preparing for and pursuing regulatory authorization culminating in submission of an IDE.
What is a "clinical prototype" in the context of this program?
Based on the description, a clinical prototype is a device built to a clinically usable standard (beyond a benchtop proof-of-concept) suitable for the type of evidence generation and documentation needed to support early clinical use and FDA review.
What types of testing does the program expect to support?
The program supports preclinical safety and efficacy testing appropriate for the technology and intended use, along with design verification and validation work to demonstrate the device meets specifications and performs as intended.
Does the program support preparing an IDE submission?
Yes. A central component is preparing for and pursuing regulatory authorization to run the clinical study, culminating in submission of an Investigational Device Exemption (IDE).
Can the award support clinical research in humans?
Yes, in a specific way. After the IDE is in place, the award can also support the initial Early Feasibility Study.
What is an Early Feasibility Study as described here?
It is typically a small, carefully monitored first-in-human study designed to evaluate basic safety, device function in the clinical environment, procedural workflow, and early signals of potential benefit, while generating information needed to refine the device and plan subsequent trials.
What outcomes or deliverables does the program emphasize?
It emphasizes deliverables that regulators and clinical trial planners care about: a device built to a clinical standard, evidence supporting reasonable safety for initial human use, documentation of verification and validation, an IDE submission, and (when supported) an early feasibility clinical dataset that informs next-stage feasibility and pivotal trials.
What are the expected next steps after completing a project under this program?
The program is designed so that, once the project is complete, the logical next steps are a larger feasibility study followed by a pivotal trial intended to support either a PMA application or an HDE, depending on the intended population and regulatory strategy.
What kinds of devices are in scope?
Therapeutic devices for neurological disorders are the focus.
Who is eligible to apply?
Eligibility is limited to U.S. small business concerns.
What basic requirements must a business meet to be considered a U.S. small business concern here?
The applicant must be organized for profit, have a place of business in the United States, and operate primarily in the U.S. (or otherwise make a significant contribution to the U.S. economy through taxes or the use of American labor or materials). The company (including affiliates) must have no more than 500 employees and must meet applicable SBIR/STTR-style ownership and control rules.
Are there specific ownership and control rules mentioned for eligibility?
Yes. The description references SBIR/STTR-style rules, including pathways that allow majority ownership by U.S. individuals or, in some cases, by multiple venture capital operating companies, hedge funds, or private equity firms, as long as no single such entity owns more than 50%.
Is cost sharing or matching required?
No. The opportunity states that no cost sharing or matching is required.
Which federal agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), specifically through NINDS.
How is this opportunity categorized administratively?
It is classified as discretionary funding using the "Health" activity category and is associated with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
Is this funding opportunity currently open for applications?
No. It was posted on July 28, 2014, with a final closing date of May 7, 2017, and an archive date of June 7, 2017. That means it is not an active competition today, but it can still be useful as a reference for the CREATE Devices program structure and expectations.
Where was the full announcement hosted?
The full announcement was hosted on the NIH grants guide site.
What is the practical problem this program is trying to solve for device teams?
It targets the translational gap where device projects often stall: turning a promising prototype into a clinically usable device backed by appropriate testing, verification/validation documentation, and a regulatory plan capable of withstanding FDA review for early human testing.
Does the program explicitly connect to FDA regulatory steps?
Yes. The program description is centered on the work required before testing in people under an IDE, includes preparation and submission of an IDE package, and frames later studies as supporting PMA or HDE strategies.
Browse more opportunities from the same category: Health
Next opportunity: NINDS CREATE Devices Translational and Clinical Studies to Inform Final Device Design (U44)
Previous opportunity: NINDS CREATE Devices Translational and Early Feasibility Studies on the Path to Pre Market Approval (PMA) or Humanitarian Device Exemption (HDE) (UH2/UH3)
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