Investigational Device Exemption (IDE) Workshop

This course will offer best practices when conducting trials using FDA approved and non-approved devices. It will cover the IDE application process and the obligations of the sponsor-investigator once the IDE application is filed with the FDA.

When May 22, 2013
from 09:00 AM to 12:00 PM
Where Brinkhous-Bullitt, Room 219
Contact Name
Contact Phone (919) 843-9514
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This workshop will address the following information:

  • Definition of a medical device
  • Examples of when an IDE is required by the FDA
  • What are PMA, 510k, and other terms used in device regulations?
  • What is an abbreviated IDE and when is this applicable?
  • What is the difference between an abbreviated IDE and a “full” IDE and when is the “full” IDE applicable?
  • How do I submit my IDE application to the FDA?
  • How do I maintain the IDE once it’s filed with the FDA?
  • How and when should I report Serious Adverse Events (SAEs) once I hold the IDE?
  • Is my trial required to be registered on Clinicaltrials.gov?
  • Roundtable discussion about the IDE process and general questions from participants
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    This course designed for anyone directly involved in conducting investigator-initiated trials:

  • Investigators
  • Regulatory Personnel
  • Clinical Research Nurses
  • Clinical Research Associates
  • To register, please visit http://tinyurl.com/cmckye6


    Investigational New Drug (IND) and Investigational Device Exemption (IDE) Workshops
    These workshops are a CTSA collaboration by the NC TraCS (Translational and Clinical Sciences) Institute and the Duke Translational Medical Institute (DTMI).

    The IND and IDE Workshops have each been pre-approved for 3 Contact Hours of Clinical Research Education for re-certification of ACRP’s CCRC®, CCRA®, CPI®, at no cost. Certificates of attendance will be available at the conclusion of the training. For nurses or others in need of Continuing Education Units, 3 CEUs are available at a cost of $6 per day (please provide payment in the form of a check and your PID number on the day of training).

    More information about this event…