Table 4.

Criteria for Treatment IDE

•The device is intended to treat or diagnose a serious or immediately life-threatening disease or condition∗

•There is no comparable or satisfactory alternative device available to treat or diagnose the disease or condition in the intended patient population

•The device is under investigation in a controlled clinical trial for the same use, or under approved IDE, or all clinical trials have been completed (but the device is not yet approved)

•The sponsor of the clinical trial is diligently pursuing marketing approval/clearance of the device

IDE = investigational device exemption.

^∗An “immediately life-threatening” disease refers to a disease in which there is a reasonable likelihood that death will occur within months or in which premature death is likely without early treatment.