IND/IDE Assistance

Investigational Device Exemption (IDE)

FDA regulations apply to products meeting the definition of a medical device. An IDE is an investigational device exemption (application).  The IDE application allows an investigational medical device to be used in a clinical study for the purpose of collecting data on safety and effectiveness.

    A.  Determining if an IDE Application is Needed

    To determine if an IDE application is needed for your clinical research or study, complete the IDE determination checklist (found under "IND/IDE").

      B.  Compiling an IDE Application

      The FDA has set forth the content and format for an IDE application.  To protect researchers and UC, HRPP staff must review IDE applications prior to submission to the FDA (per UC HRPP policy III.08) whenever a UC researcher is serving as Sponsor-Investigator (the person who both initiates an FDA regulated study and has the regulatory responsibility; sponsor in this roles is not related to funding).  Also see definition according to 21 CFR 312.3(b).

      If you have questions regarding compiling and maintaining an IND application, please contact Angela Braggs-Brown or Kareemah Mills.

      C.  IDE Application Approval Process

      Following submission, the FDA will send the sponsor notification that the IDE application has been received and the date of receipt. FDA may accept the application, request additional information or modifications. An clinical investigation may begin after IRB approval and after 30 days from the date of receipt on the FDA acknowledgement letter, unless FDA informs the sponsor that it may not begin.

      In certain cases, the proposed clinical investigation of a medical device may be exempt from the requirement to submit an IDE application. Exempt medical devices must still comply with abbreviated IDE requirements (21 CFR Part 812.2(b)) including those associated with labeling (21 CFR Part 801.1; 21 CFR Part 812.5; 21 CFR Part 809.10(c)) and monitoring (21 CFR Part 812.46).

      D.  Maintaining an IDE Application

      Research must be conducted in compliance with FDA regulations as well as UC policies and procedures.  Researchers must obtain both FDA approval of the IDE application, as well as IRB approval of the protocol.  All aspects of the study are subject to auditing by the FDA, the UC IRB, and it's designees.


      Contact Us


      Human Research Protection Program
      (ML0567)
      University Hall, Suite 300
      51 Goodman Drive
      PO Box 210567
      Cincinnati, OH 45221-0567
      General Inquiries:
      513-558-5259
      irb@ucmail.uc.edu

      Click here to identify the person dedicated to serving your research group

       

      Angela Braggs-Brown, RAC, CIP, MA
      Director
      513-558-3005
      angela.braggs-brown@uc.edu

      Kareemah Mills, CIP
      Assistant Director
      513-558-3576
      kareemah.mills@uc.edu

      Claudia Norman, CIP
      Education and Outreach Specialist
      513-558-5784
      claudia.norman@uc.edu

      Human Protection Administrators

      Laura Goins
      513-558-0479
      laura.goins@uc.edu

      Martina Harmon, MS
      513-558-1881
      martina.harmon@uc.edu

      Tara Knipp, CIP
      513-558-3731
      tara.knipp@uc.edu

      Christa Preston, CIP
      513-558-2087
      christa.preston@uc.edu

      Deborah Quinones-Stewart
      513-558-6915
      deborah.quinones-stewart@uc.edu

      Quality Assurance Auditors
      Jackie Glass, CCRP
      513-558-0453
      jacklyn.glass@uc.edu

      Brianna Mills
      513-558-2286
      brianna.mills@uc.edu

      StrokeNet CIRB
      Susan Roll, RN, BSN, CCRP
      CIRB Liaison
      513-558-6061
      susan.roll@uc.edu

      Jo Ann Behrle
      Human Protection Administrator
      513-558-5273
      joann.behrle@uc.edu

      Keeley Lynch
      CIRB Coordinator
      513-558-5209
      keeley.lynch@uc.edu