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.

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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.