Clinical Trials and Devices

This page provides comprehensive information on Clinical Trials, IDEs (Investigational Device Exceptions), HDEs (Humanitarian Device Exemptions), HUDs (Humanitarian Use Devices), PMAs (Pre-Market Approvals), PMA Post-Approval Extension Studies, PMN (Pre-Market Notification) (510(k)), and TAVR (Transcatheter Aortic Valve Replacement). It is our hope that the information provided will make the submission of your approval request easier and more efficient.