CREATE Therapeutic Devices

CREATE BIO program overview diagram


CREATE Devices overview diagram

General Information

The Translational Neural Devices program provides support for translational activities and small clinical studies to advance the development of therapeutic or diagnostic devices that affect the nervous or neuromuscular systems. The pre-clinical/translational device activities, including translational bench and animal studies, are expected to lead to an Investigation Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to support a small clinical trial, or a Non-Significant Risk (NSR) designation from an Institutional Review Board (IRB) indicating that the study does not require an IDE. This cooperative agreement program will also support the subsequent small clinical trial to collect safety and effectiveness data required to support a marketing application, or to inform final device design.

RFA-NS-18-011: For academic and businesses that are not SBIR eligible
RFA-NS-18-012: For small businesses that are SBIR eligible

Tools & Resources

Out of Scope Activities

For the purposes of this program announcement technologies for augmentation of healthy individuals, rehabilitation strategies, imaging technologies, diagnostics and diagnostic devices are not considered therapeutic devices and should not be submitted. In addition, the following activities are also not within scope:

  • Basic research and studies of disease mechanisms
  • Animal model development: All in vivo models must have been established and characterized in the applicants or collaborators laboratory.
  • Definitive clinical trials, such as a full Feasibility study and/or Pivotal Trial
  • Applications without pre-clinical testing or activities
  • Applicants proposing clinical trials or biomarker studies that fall outside of the scope of this FOA may wish to consider applying to the NINDS NeuroNEXT clinical trials program, the NINDS Exploratory Clinical Trials program (PAR-17-122), or to the NIH StrokeNet program for stroke indications
  • Efforts to develop neurotechnology for fundamental study of the nervous system
  • Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses are outside the scope of the present FOA but may be within scope of the Bioengineering Research Grants and Partnerships program announcements.

Applicants are strongly encouraged to contact program staff at least 12 weeks prior to the application deadline.