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. 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 investigational plan approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by the FDA;
Informed consent from all patients;
Labeling stating that the device is for investigational use only;
Monitoring of the study
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 (FD&C Act) that would apply to devices in commercial distribution. Please click here to contact us to learn more about the IDE process and how we can assist you.