This funding supports small clinical trials to generate critical data on next-generation devices for recording and modulating the human central nervous system. Eligible studies include Non-Significant Risk and Significant Risk devices requiring FDA Investigational Device Exemption. The trials aim to answer key questions about device function or design that cannot be addressed through non-clinical testing. Devices may be accessed via the BRAIN Public-Private Partnership, facilitating clinical research on innovative technologies for CNS disorders.
Eligible applicants include Native American tribal governments, small businesses, state and local governments, nonprofits, institutions of higher education, and other specified organizations. Foreign organizations are not eligible to apply, but foreign components of U.S. organizations are allowed.
