Notice of Funding Opportunity (NOFO) for First-in-Human or Early Stage Clinical Studies for Recording and/or Stimulating Devices
Department of Health and Human Services ▸ 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
Funding Source
Department of Health and Human Services ▸ National Institutes of Health ▸
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)
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