I believe in order to use an unapproved device, Physician’s must understand their role and responsibilities. And also understand when an emergency is to use an unapproved device. For a situation to be an emergency, there must be a life-threatening disease or serious condition which is requiring immediate use. There is no generally accepted alternative available for treating the condition. Lastly, there is no time to use existing procedures to obtain FDA approval of an IDE. Before using, it is the Physician’s role to assess the potential for benefits from the unapproved use and have substantial reason to believe that benefits will exist.