NINDS CREATE Devices: Translational and Clinical Studies on the Path to 510(k) (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 the immediate next steps upon completion of the clinical study will be a 510(k)/510(k) De Novo submission or a larger clinical trial that will lead directly to a 510(k)/510(k) De Novo submission. 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-14-296, 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-14-297, UH2/UH3 Phase Innovation Awards Cooperative Agreement

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-14-295 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 Pre-Market Approval (PMA) or Humanitarian Device Exemption (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-14-299). Projects to enable Investigational Device Exemption (IDE) submission, where the early clinical studies would inform a final device design that would have to go through most - if not all - of the bench-top and preclinical animal testing on the path to clinical trial and market approval, are not within the scope of this program announcement.  These projects should apply to the Translational and Clinical Studies to Inform Final Device Design FOA (PAR-14-300).

Funding Type

Grant

Eligibility

Faculty

Category

Medical
Medical - Clinical Science
Medical - Translational

External Deadline

February 8, 2017