EMERGENCY USE

Expanded Access-Single Patient Emergency Use of Investigational Drug/Biologic/Device

The FDA defines "emergency use" as the use of a test article (drug, device or biologic) when:

  1. The patient has a life-threatening* condition that needs IMMEDIATE treatment.
  2. No generally acceptable alternative treatment for the condition exists; and
  3. There is no time to obtain FDA or IRB approval prior to the use.

*Life-threatening, for the purposes of section 56.102(d), includes the scope of both life-threatening and severely debilitating, as defined below.

  • Life-threatening means 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 patients must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.
  • Severely debilitating means 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.

NOTE: Emergency Use single patient treatment, you are NOT required to secure FDA and IRB approval PRIOR to the use of the investigational test article.  Notification to the IRB  must occur no later than 5 working days following administration of the investigational test article.  If time permits, you may submit all documentation ahead of administration.

UVA Study teams are NOT required to go through CRConnect or Protocol Builder for a single patient emergency use of an investigational test article.

 

Procedures for IRB submission for Single Patient Emergency Use of an Investigational Drug/Biologic

 

Send the following documentation to the UVA IRB via IRBHSR@virginia.edu

Subject Line: Single Patient Emergency Use of Investigational Drug or Biologic

 

 

 

Procedures for IRB submission for Single Patient Emergency Use of an Investigational Medical Device

Send the following documentation to the UVA IRB via IRBHSR@virginia.edu

Subject Line: Single Patient Emergency Use of an Unapproved Medical Device 

  • Expanded Access- Single Patient Emergency Use of Investigational Device
  • Obtain a written independent assessment of the use of the device by an uninvolved, independent physician (See Part 3 of form above) .
  • IDE protocol or treatment plan with description of device and name of IDE holder, if this exists.
  • Study specific informed consent-See UVA Template
  • Copy of Authorization from the IDE holder
  • Obtain clearance from Clinical Engineering for use of the unapproved investigational medical device (New Medical Device application)
  • IDE# and FDA Acknowledgment

Additional information:

Expanded Access for Unapproved Medical Devices

Expanded Access for Unapproved Drugs and Biologics