Investigational Device Exemption (IDE)

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.

Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.

All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

Clinical evaluation of devices that have not been cleared for marketing requires:

• an IDE approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA;
• informed consent from all patients;
• labeling for investigational use only
• monitoring of the study and;
• required records and reports.

An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (Act) that would apply to devices in commercial distribution.

Sponsors need not submit a PMA or Premarket Notification 510(k), register their establishment, or list the device while the device is under investigation. Sponsors of IDE's are also exempt from the Quality System (QS) Regulation except for the requirements for design control.