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Investigational Device Exemption Workshop
March 12, 2021 @ 9:00 am - 11:00 am
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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