Duke SOM: Investigational Device Exemption Workshop

Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator Investigational Device Exemptions (IDEs)

The Duke University School of Medicine Office of Regulatory Affairs and Quality is conducting an IDE Workshop co-sponsored by the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD).

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

Presenters

Alysa Vereen, PharmD, Regulatory Affairs Scientist, Duke University School of Medicine
David Jensen, PhD, RAC, Regulatory Affairs Scientist, Duke University School of Medicine

Register

NC TraCS Regulatory Support is available to provide guidance and assistance with IND and IDE submissions and understanding the regulatory requirements for Federally-regulated studies. UNC Investigators and study teams with questions about regulatory submissions and pathways can submit a request to speak with an expert.

See also: IND workshop Mar 5