Investigational Device Exemption (IDE) Workshop

When May 30, 2014
from 01:00 PM to 04:00 PM
Where Brinkhous-Bullitt Room 219
Contact Name
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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. 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

This course is designed for anyone directly involved in conducting investigator-initiated trials:

  • Investigators
  • Regulatory Personnel
  • Clinical Research Nurses
  • Clinical Research Associates

This workshop is a CTSA collaboration by the NC TraCS (Translational and Clinical Sciences) Institute and the Duke Translational Medical Institute (DTMI).

More information about this event…