The Office of Regulatory Affairs and Quality (ORAQ) is hosting a "The Investigational Device Exemption (IDE) Workshop" on March 12 from 9 to 11 a.m.

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

• Review case scenarios

Don't forget to register!