Devices and Instrumentation Overview

Regulation

Once a device becomes FDA approved and available, the physician can use the device in any manner (off-label) that he/she desires if it is in the best interest of the patient and supported by objective and appropriate peer-reviewed scientific and clinical information. This is termed the “practice of medicine.” No investigational device exemption or institutional review board review is needed in these types of cases. A 2nd very different type of off-label use involves experimental or investigational devices. In these cases, clinical use requires an investigational device exemption and the implant can only be used in accordance with the device's approved investigation plan. The patient must provide a formal informed consent for that device. Finally, the device cannot be shared with other physicians outside the formal study plan.