The use of unapproved devices during emergency is allowed but is conditional. The emergency situation is when there is a life threatening disease or condition that requires immediate use and no available alternative for life threatening condition. In such cases there is no time to obtain FDA approval. This condition is to be identified by the physician that is operating on the patient.

The conditions to use the unapproved devices are given as:
There is no IDE(Investigational Device Exemption.
Physician wants to use the device in a way not part of the IDE study.

The physician is allowed to use unapproved products but should also follow protection measures such as to use on single patient or small group only, takes sponsors authorization and sponsors IDE should be submitted.