NINDS CREATE Devices: Translational and Early Feasibility Studies on the Path to Pre-Market Approval (PMA) or Humanitarian Device Exemption (HDE) (UH2/UH3)
Post Date
July 28th 2014
Application Due Date
May 7th 2017
Funding Opportunity Number
PAR-14-298
CFDA Number(s)
93.853
Funding Instrument Type(s)
Cooperative Agreement
Funding Activity Categories
Eligibility Categories
State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other
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.
Funding
-
Award Range:
$None - $None
Grant Description
The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and Early Feasibility 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), 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.
Contact Information
-
Agency
Department of Health and Human Services
-
Office:
National Institutes of Health
-
Agency Contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV -
Agency Mailing Address:
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster
- Agency Email Address:
- More Information:
Get A Free Grant Assistance Kit
To start your application for a free grant package go to: