Presentation: Overview of US FDA Investigational Device Exemption (IDE)

Reviewed Topics:

  • What is an IDE?
  • What Clinical Studies Need an IDE?
  • When do you Need to Submit an IDE ?
  • What Devices are Exempt from IDE?
  • What ids the Content of an IDE Application?
  • What are the Timelines for FDA Review of IDE?
  • What Happens after FDA Reviews an IDE?