Loading Events

« All Events

  • This event has passed.

Investigational Device Exemption Workshop

March 12 @ 9:00 am - 11:00 am

This workshop will:
• Discuss FDA’s approach to regulation of devices in clinical studies and for marketing
• Provide guidance on when the IDE regulations apply and discuss possible exemptions
• Review significant risk and non-significant risk device studies
• Discuss the preparation, submission, and maintenance of IDE applications
• Encourage participant discussion of case scenarios

Registration required.