Translational Neural Devices (U44, UG3/UH3 Clinical Trial Required)

Funding Agency:
National Institutes of Health

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to pursue translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The translational device activities, including translational bench and animal studies, are expected to lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. This cooperative agreement will also support the subsequent small clinical study to collect safety and effectiveness data required to support a marketing application or to inform final device design.

Companion FOA: RFA-NS-18-011, UG3/UH3 Innovation Awards Cooperative Agreement


  • Letter of Intent: 30 days prior to the receipt date
  • U01 Deadlines: February 21, 2018; June 21, 2018; October 22, 2018; February 21, 2019; June 21, 2019; October 21, 2019; February 21, 2020; June 22, 2020; and October 21, 2020; February 22, 2021
  • UG3/UH3 Deadlines: February 21, 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-18-012 Expiration Date: New Date February 23, 2021 per issuance of NOT-NS-20-102. (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

Applicants should rarely exceed $1,000,000 in total costs 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 SBIR Phase I and up to 3 years for SBIR Phase II may be requested.

Funding Type





Engineering and Physical Sciences
Medical - Clinical Science
Medical - Translational

External Deadline

October 21, 2020