Clinical Evaluation Reports

Ethics Review

Regulatory review/ Investigational Device Exemption

An investigational device exemption (IDE) (21CFR 812) 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 [510(k)] submission to FDA. All aspects of the IDE process are described by the FDA.

 

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