NINDS CREATE Devices: Translational and Clinical Studies on the Path to 510(k)(UH2/UH3)

 
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    CFDA#

    93.853
     

    Funder Type

    Federal Government

    IT Classification

    B - Readily funds technology as part of an award

    Authority

    U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH)

    Summary

    This program seeks to encourage the translation of research discoveries into new treatments for neurological disorders and stroke that fall under the National Institute of Neurological Disorders and Stroke (NINDS) mission.

    This program will utilize a UH2/UH3 cooperative agreement mechanism to support pre-clinical testing to enable an Investigational Device Exemption (IDE) submission or IRB approval for a Non-Significant Risk (NSR) study and the subsequent clinical study. This program supports pre-clinical and small clinical studies where the immediate next steps upon completion will be a 510(k)/510(k) De Novo submission or a larger clinical trial that will lead directly to a 510(k)/510(k) De Novo submission. It is expected that changes to the system design informed by the Early Feasibility Study will be minor and not require additional animal testing. Activities that can be supported in this program include implementation of clinical prototype devices, design verification and validation activities, demonstration of preclinical safety and efficacy, pursuit of U.S. regulatory approval for clinical study, and small clinical studies.

    Projects must focus on a single disorder that falls within the mission of NINDS. Devices within the scope of this program are expected to be very close to the 'final system' and manufactured using very close to the same manufacturing process for any subsequent clinical studies and eventual market manufacture. If a subsequent larger clinical study is required for market approval, it is expected that any changes to the manufacturing process or the final system design informed by this small clinical study will be minor, and will not require additional pre-clinical data or clinical data prior to conducting the larger clinical study.

    For entry to the program, projects should have:

    • Comprehensive Supporting Data: Ideally, preliminary proof-of-concept data would be obtained using an in vivo model representative of the intended patient population.
    • A compelling case to for a successful IDE submission by the end of the UH2 or IRB approval for a Non-Significant Risk (NSR) study at the end of the UH2.
    • Overall device development plan, including when contact with the appropriate regulatory bodies is planned, clinical considerations, and a needs assessment.
    • Identified one or more clinically meaningful device outcome measures based on input from both clinicians and patients
    • Non-binding FDA Pre-Submission (formerly pre-IDE) feedback clearly denoting that the proposed pre-clinical testing plan is sufficient to support a successful FDA submission for an IDE by the end of Phase I. For Non-Significant Risk (NSR) studies, preliminary communications (e.g. letter or other documentation) with the IRB indicating what pre-clinical testing will be necessary to support the NSR clinical study is sufficient.
    Examples of studies that can be proposed during the UH2 phase include, but are not limited to:

    • Non-GLP (Good Laboratory Practice) animal studies to develop surgical techniques relevant to the device, define relevant therapeutic parameters, and refine device design in preparation for subsequent GLP testing for regulatory approval
    • In vitro and animal testing to meet FDA Recognized ISO/ASTM Standards
    • Activities to become GMP (Good Manufacturing Practice) compliant
    • Activities to bring the development process under Design and Quality Systems Control
    • Device, software, and firmware design verification and validation activities
    • Regulatory affairs
    • GLP compliant large animal model safety and/or testing of an implanted device
    • IDE submission
    The UH3 will support a small clinical study that will lead to either a 510(k)/510(k) De Novo submission or a larger clinical trial leading directly to a 510(k)/510(k) De Novo submission. It should be noted that clinical studies are only supported for projects where the preclinical activities are conducted under this program.
     

    History of Funding

    None is available.

    Additional Information

    Examples of Activities Inappropriate for this program include:

    • Basic research and studies of disease mechanisms
    • Animal model development: All in vivo models must have been established and characterized in the applicants or collaborators laboratory.
    • Development of diagnostics, or diagnostic devices.
    • Rehabilitation strategies.
    • Imaging technologies.
    • Definitive clinical trials of therapeutic devices, such as a full Feasibility study and/or Pivotal Trial
    • Pre-clinical studies and related clinical studies to enable 510(k) or 510(k) De Novo submission
    • Pre-clinical studies to enable IDE submission, where the immediate next steps upon completion of an Early Feasibility Study will be a full Feasibility Study and a Pivotal Trial in support of a PMA (Pre-Market Approval) or HDE (Humanitarian Device Exemption), i.e. changes to the system design informed by the Early Feasibility Study will be minor and not require additional animal testing.
    • Efforts to develop neurotechnology for fundamental study of the nervous system.
    • Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses are outside the scope of the present program but may be within scope of the Bioengineering Research Grants and Partnerships program announcements.
    • Projects focused on neural prosthetic technologies for augmentation of healthy individuals.

    Contacts

    Tijuanna Decoster, Ph.D.

    Tijuanna Decoster, Ph.D.
    U.S. Department of Health and Human Services (HHS)
    National Institute of Neurological Disorders and Stroke (NINDS)
    NSC BG RM 3258
    6001 Executive Blvd Mail Stop: 9537
    Rockville, MD 20852
    (301) 496-9231
    (301) 402-0219
    For a complete list of contacts, please see the guidance.
     

  • Eligibility Details

    Eligible applicants include:

    • Higher Education Institutions
      • Public/State Controlled Institutions of Higher Education
      • Private Institutions of Higher Education
      • The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
        • Hispanic-serving Institutions
        • Historically Black Colleges and Universities (HBCUs)
        • Tribally Controlled Colleges and Universities (TCCUs)
        • Alaska Native and Native Hawaiian Serving Institutions
        • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
    • Nonprofits Other Than Institutions of Higher Education
      • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
      • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • For-Profit Organizations
    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)
    • Governments
      • State Governments
      • County Governments
      • City or Township Governments
      • Special District Governments
      • Indian/Native American Tribal Governments (Federally Recognized)
      • Indian/Native American Tribal Governments (Other than Federally Recognized)
      • Eligible Agencies of the Federal Government
      • U.S. Territory or Possession
    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations

    Deadline Details

    All non-AIDS applications must be submitted by 5:00 p.m. local time of applicant organization on the following dates: October 21, 2014; February 11, 2015; August 11, 2015; February 11, 2016; August 11, 2016; February 8, 2017.

    All AIDS applications must be submitted by 5:00 p.m. local time of applicant organization on the following dates: January 7, 2015; May 7, 2015; September 7, 2015; May 7, 2016; September 7, 2016; May 7, 2017. 

    Award Details

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but must reflect the actual needs of the proposed project. Applicants should rarely exceed $1,000,000 direct costs per year for the UH2 phase and $1,500,000 direct costs per year for the UH3 phase. the proposed project period for the UH2 phase must not exceed 3 years. The proposed project period for the UH3 phase must not exceed 4 years. The total duration of the UH2 and UH3 may not exceed 5 years. Cost sharing/matching is not required.

    Related Webcasts Use the links below to view the recorded playback of these webcasts


    • Highlights of Grants to Manage and Expand Access to Health Data - Sponsored by NetApp - Playback Available
    • Funding for Healthcare Technology to Connect Providers and Patients - Sponsored by Panasonic - Playback Available
    • NSF Funding for Campus Cyberinfrastructure in Higher Education - Sponsored by NetApp - Playback Available

 

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