IDE Early/Expanded Access

An unapproved medical device may normally only be used on human subjects through an approved clinical study in which the subjects meet certain criteria and the device is only used in accordance with the approved protocol by a clinical investigator participating in the clinical trial.

However, there may be circumstances under which a health care provider may wish to use an unapproved device to save the life of a patient or to help a patient suffering from a serious disease or condition for which there no other alternative therapy exists.

Patients/physicians faced with these circumstances may have access to investigational devices under one of four main mechanisms by which FDA may make an unapproved device available:

• Emergency Use
• Emergency Research
• Compassionate Use (or Single Patient/Small Group Access)
• Treatment Use
• Continued Access