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I have a device that has not been cleared for marketing in the US – but I have to do a clinical evaluation.  What do I need to do?

Clinical evaluation of devices that have not been cleared for marketing requires:

• an IDE approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA;
• informed consent from all patients;
• labeling for investigational use only
• monitoring of the study and;
• required records and reports.