Investigational Device Exemptions submissions

An investigational device exemption (IDE) is required for a device that will be used in clinical trials to support a PMA submission. IDE s are also required for clinical evaluation of certain modifications to or new intended uses of legally marketed devices. An IDE may be granted by the Institutional Review Board (IRB) at the facility where the investigational study will take place. The FDA must also approve the IDE if significant risk is involved. 

As summarized by the FDA, an investigational device exemption (IDE) allows a device to be used in a clinical study to collect safety and effectiveness data required to support a PMA application or a Premarket Notification [510(k)j submission to FDA. All clinical evaluations of investigational devices must have an approved IDE before a clinical study can be initiated. 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 Eood, Drug, and Cosmetic Act that would apply to devices in commercial distribution (FDA, 2009). 

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