Notice of Funding Opportunity (NOFO) for First-in-Human or Early Stage Clinical Studies for Recording and/or Stimulating Devices

National Institutes of Health

Description

This grant opportunity is for studies needing FDA approval (IDE) for high-risk medical devices like chronic implants. The research should provide essential data on the device's function or design. It's part of a cooperative agreement with the NIH, which means NIH staff will help finalize the project plan and oversee its progress. This program is also linked to the BRAIN Initiative and involves partnerships with device manufacturers through the BRAIN Public-Private Partnership Program.

This NOFO supports Significant Risk (SR) studies requiring an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical study is expected to provide data to answer key questions about the function or final design of a device. This NOFO is part of a milestone-dri…

Source

Grant ID

RFA-NS-25-022

Agency

National Institutes of Health

Subcategory/Subagency

National Institute of Neurological Disorders and Stroke

Key Dates

Opportunity Released

November 5, 2024

Submission Deadline

September 28, 2026

Application Window Closes

September 28, 2026

Open for Submission

November 5, 2024

Eligibility

The following categories of applicants are invited to apply:

  • Public/State-Controlled Institutions of Higher Education
  • Private 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)
  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Local Governments
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Public Housing Authorities/Indian Housing Authorities
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Independent School Districts
  • U.S. Territory or Possession
  • Eligible Agencies of the Federal Government
  • Indian/Native American Tribal Governments (Federally Recognized)
Additional Eligibility Information
Foreign/non-domestic entities (foreign organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. Required registrations (must be completed and active prior to submission; can take 6+ weeks): System for Award Management (SAM) with annual renewal; Unique Entity Identifier (UEI) via SAM; eRA Commons (with at least one Signing Official and one PD/PI ac…
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