BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44 Clinical Trial Required)

Funding Agency:
National Institutes of Health

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue translational non-clinical studies and clinical studies for recording and/or stimulating devices to treat nervous system disorders and thereby better understand the human brain.  The program will utilize a cooperative agreement mechanism to support the non-clinical studies necessary for the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and the subsequent small clinical trial (e.g., Early Feasibility Study).  Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical trial. The small clinical trial should provide data to answer key questions about the function or final design of a device.  This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval.  The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.  


  • Letter of Intent: 30 days prior to the receipt date
  • Application Due Date(s): February 23, 2018, June 21, 2018, October 22, 2018, February 21, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 22, 2021

RFA-NS-18-022 Expiration Date New Date February 23, 2021 per issuance of NOT-NS-20-104. (Original Expiration Date: October 22, 2020)

Agency Website

Eligibility Requirements

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. 

Amount Description

Application budgets are not limited but must reflect the actual needs of the proposed project.

Applications should rarely exceed $1,000,000 in total cost per year during the SBIR Phase I and $1,500,000 in total costs per year during the SBIR Phase II.

Durations up to 2 years for Phase I and up to 3 years for Phase II may be requested.

Funding Type





Engineering and Physical Sciences
Medical - Basic Science
Medical - Clinical Science
Medical - Translational

External Deadline

October 21, 2020