When a physician uses unapproved medical devices it risks the safety and health of patients. Such medical devices should not be available during regular clinical care. FDA recognizes the emergency use of a investigational devices in a immediate life threating situation when no standard treatments are available and there is no time available to obtain full IRB review. The physician first seek the permission of sponsor or IRB if they disagree physician cannot use the device. The sponsor needs to submit IDE supplement to FDA. If the FDA approved there should be an informed consent document from the patient. The physician would need to report the IRB after the use of device. The IRB will review the submission of any issues from the physician. If the device is used during clinical research the patient must not meet the inclusion criteria and the data obtained should not be included in research.