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Cooperative Research to Enable and Advace Translational Enterprises-Devices


CREATE Branding

 

CREATE Devices Program Overview

CREATE: Therapeutic Devices

General Information

The CREATE Devices program provides support for projects that focus on pre-clinical and pilot clinical studies for therapeutic devices. There are three tracks for devices: 

  1. Translational and Clinical Studies to Inform Final Device Design will support 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. Preclinical work should lead to an Investigational Device Exemption (IDE) to support a clinical study, or a Non-Significant Risk (NSR) study that does not require an IDE. 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 bench-top and preclinical animal testing on the path to clinical trials and market approval. 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 clinical study.

        PAR-14-300: For small businesses that are SBIR eligible (http://www.ninds.nih.gov/funding/small-business/small_business_STTR_SBIR_eligibility_summary.htm)

        PAR-14-297: For academic and businesses that are not SBIR eligible

  1. Translational and Clinical Studies on the Path to 510(k) will support preclinical studies and the following IDE-enabled or NSR studies.  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 clinical study.

        PAR-14-296: For small businesses that are SBIR eligible (http://www.ninds.nih.gov/funding/small-business/small_business_STTR_SBIR_eligibility_summary.htm)

        PAR-14-295: For academic and businesses that are not SBIR eligible

  1. Translational and Early Feasibility Studies on the Path to Pre-Market Approval (PMA) or Humanitarian Device Exemption (HDE) will support applications to pursue preclinical studies for an IDE submission, with the option of also supporting the following Early Feasibility Study..   It is expected the immediate next steps upon completion of the Early Feasibility Study will be a full Feasibility Study and a Pivotal Trial in support of a PMA (Pre-Market Approval) or HDE (Humanitarian Device Exemption). 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 an Early Feasibility Study.

        PAR-14-299: For small businesses that are SBIR eligible (http://www.ninds.nih.gov/funding/small-business/small_business_STTR_SBIR_eligibility_summary.htm)

        PAR-14-298: For academic and businesses that are not SBIR eligible

A decision tree  (http://www.ninds.nih.gov/funding/areas/translational_research/decisiontree/OTR_Decision_Tree_device.pdf) is available to help applicants determine the best program announcement. Applicants are also encouraged to read the frequently asked questions (CREATE FAQ).

 

Program Contact:

Applicants are strongly encouraged to contact Stephanie Fertig (fertigs@ninds.nih.gov or 301-496-1779) at least 12 weeks prior to the application deadline.

Last updated July 30, 2014