The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency — making important discoveries that improve health and save lives.
The aim of this Funding Opportunity Announcement (FOA) is to support investigators in conducting small clinical trials that provide critical data necessary for the advancement of recording and/or stimulating devices aimed at treating disorders of the central nervous system and enhancing understanding of the human brain. These clinical trials may involve procedures that are categorized as either Non-Significant Risk (NSR) or Significant Risk (SR), including chronic implants that necessitate an Investigational Device Exemption from the FDA. The trials should generate essential data on the device's function or final design, information that is unattainable through non-clinical assessments due to the device's novelty or unique application. This initiative supports small clinical trials to answer pivotal questions about a device's operation or ultimate configuration.