Simpler Grants.gov #RFA-NS-25-022

NIH BRAIN Initiative Clinical Studies for Next-Generation CNS Devices

The National Institutes of Health (NIH) is inviting proposals for clinical studies under the BRAIN Initiative to develop and evaluate next-generation devices for recording and modulation in the human central nervous system (CNS). - Government Buyer: - National Institutes of Health (NIH) - Products/Services Requested: - Clinical trials to assess the function or final design of CNS devices - Studies may include: - Non-Significant Risk (NSR) procedures as determined by an Institutional Review Board (IRB) - Significant Risk (SR) studies requiring FDA Investigational Device Exemption (IDE), such as chronic implants - OEMs and Vendors: - No specific OEMs or device models are named in the solicitation - Includes a Public-Private Partnership Program (BRAIN PPP) to facilitate access to devices and capabilities from device manufacturers - Unique/Notable Requirements: - Focus on small clinical trials that generate data not obtainable through non-clinical assessments - Supports both acute/short-term and chronic/long-term device studies - Open to a broad range of applicants: government, nonprofit, business, and educational organizations - Aims to support the path to advanced clinical trials and eventual market approval for CNS devices

Description

This funding opportunity encourages investigators to conduct small clinical trials to obtain critical information necessary to advance recording and/or stimulating devices for treating central nervous system disorders and better understanding the human brain. Supported clinical studies may include acute or short-term procedures classified as Non-Significant Risk by an IRB or Significant Risk studies requiring FDA Investigational Device Exemption. The trials aim to provide data on device function or final design that cannot be obtained through non-clinical assessments, supporting the path to advanced clinical trials and market approval. The initiative includes a Public-Private Partnership Program with device manufacturers to facilitate access to devices for clinical research.

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