OpportunityTitle: NINDS CREATE Devices: Translational and Clinical Studies on the Path to 510(k) (UH2/UH3)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:  Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Description: 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.
GrantorContactEmailDescription: If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster
GrantorContactText: NIH OER Webmaster&lt;br/&gt;FBOWebmaster@OD.NIH.GOV&lt;br/&gt;