AdvaMed IDE Submissions Workshop

February 26, 2020

IDE Submissions Workshop - Spring 2020
February 26, 2020
Irvine, CA

During this interactive workshop, FDA and industry experts will lead you through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required.

Agenda topics include:

  • The purpose of an IDE
  • Tips on making the best use of pre-submission meetings
  • Components of a successful IDE submission
  • Common errors and deficiencies in an IDE application
  • The ins and outs of BIMO inspections
  • Details about the regulatory requirements needed during trial conduct
  • And more!

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