To qualify as an emergency under FDA regulations, the proposed use must meet the following criteria, which differ for drugs/biologics and devices.

For a drug or biologic:

• Patient is in a life-threatening or severely debilitating situation
• No standard acceptable treatment is available; AND
• There is insufficient time to obtain IRB approval prior to the proposed date of use.

For a device:

• Patient has a life-threatening condition that needs immediate treatment;
• No generally acceptable alternative treatment for the condition exists; AND
• There is insufficient time to obtain IRB approval prior to the proposed date of use.
• Because of the immediate need to use the device, there is not time to use existing procedures to obtain FDA approval for the use.

The FDA defines life-threatening as diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.

The FDA defines severely debilitating as diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness; loss of arm, leg, hand or foot; loss of hearing; paralysis or stroke.