An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study to collect safety and effectiveness data, which can be required for Pre-Market Approval applications or a Pre-Market Notification. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluation of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
We provide support for Investigational Device Exemption requirements. Please contact us for more information.