IDE: Investigational Device Exemption
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification (510K). Involved in this process is an approved clinical protocol, administrative monitoring plan, IRB approval, patient informed consent form, etc. in order for the manufacturer to gather the clinical information on humans to establish the safety and effectiveness data.
Whatever the route required for your company's medical product, we are experienced in every aspect of the process and will assist you in addressing the following mandatory IDE requirements: