Investigational Device Exemption (IDE)

An Investigational Device Exemption (IDE) allows an unapproved medical device—or an approved device being evaluated for a new indication or population—to be legally shipped and used in a U.S. clinical study. 

IDE approval is required for any clinical study involving patients, except for non-significant-risk studies or certain low-risk IVD studies. 

A successful IDE submission includes relevant documents and data demonstrating the safety of the investigational device. 

Let us help you with your IDE!