NINDS CREATE Devices: Translational and Clinical Studies to Inform Final Device Design (UH2/UH3)

Funding Agency:
National Institutes of Health

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and clinical studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) or IRB approval for a Non-Significant Risk (NSR) study and the following clinical study. It is expected that the clinical study will inform a final device design that would have to go through most, if not all, of the preclinical testing on the path to more advanced clinical trials and market approval. This program also supports development of a device to test scientific hypotheses that are not feasible or practical to conduct in animal models, but are critical to enable next-generation devices. Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and a small clinical study.  

Companion FOAs:

PAR-14-295, UH2/UH3 Phase Innovation Awards Cooperative Agreement

PAR-14-296, U44 Small Business Innovation Research (SBIR) Cooperative Agreement – Fast-Track

PAR-14-299, U44 Small Business Innovation Research (SBIR) Cooperative Agreement – Fast-Track

PAR-14-300, U44 Small Business Innovation Research (SBIR) Cooperative Agreement – Fast-Track

PAR-14-298, UH2/UH3 Phase Innovation Awards Cooperative Agreement  

Deadlines:

  • Application Due Date(s): October 21, 2014; February 11, 2015, August 11, 2015, February 11, 2016, August 11, 2016, February 8, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
  • AIDS Application Due Date(s): January 7, 2015; May 7, 2015; September 7, 2015; May 7, 2016; September 7, 2016; and May 7, 2017, by 5:00 PM local time of applicant organization.

PAR-14-297 Expiration Date May 8, 2017
 

Agency Website

Areas of Interest

The CREATE Devices program consists of three FOAs focused on different device development tracks and applicants should apply to the appropriate track for their technology. Applicants should apply to only one track per project. Projects to enable clinical studies where the immediate next step upon completion of the study is a subsequent full Feasibility Study and a Pivotal trial to support a PMA or HDE are not within scope of this FOA.  Such projects - where changes to the system design informed by the Early Feasibility Study will be minor and not require additional animal testing - should instead apply to the 'Translational and Early Feasibility Studies on the Path to Pre-Market Approval (PMA) or Humanitarian Device Exemption (HDE) FOA (PAR-14-298).  Similarly, projects to directly enable a 510(k) submission are also not within scope and should apply to the Translational and Clinical Studies on the Path to 510(k) FOA (PAR-14-295).

Funding Type

Grant

Eligibility

Faculty

Category

Medical
Medical - Clinical Science
Medical - Translational

External Deadline

February 8, 2017