Single Patient Emergency or Compassionate Use
These documents provide instructions for UW physicians who wish to use an investigational drug, device or biologic for clinical treatment of a single patient. FHCC physicians may use this process for emergency, but not compassionate uses.
- APPLICATION Notification of Emergency Use, Drug or Biologic
- APPLICATION Notification of Emergency Use, Device
- APPLICATION Notification of Compassionate Use, Device
- TEMPLATE Consent Form, Emergency or Compassionate Use
- All requirements are described in the APPLICATION documents.
- It is not necessary to obtain the concurrence of an IRB chair or to inform the Human Subjects Division (HSD) before the emergency or compassionate use.
- The special consent template listed above must be used to ensure compliance with FDA regulations.
What is the difference between emergency use and compassionate use?
The Single Patient Emergency and Compassionate Use mechanisms allow for use of investigational drugs, biologics, or devices to treat or diagnose patients when specific criteria are met. Both types of use are generally intended for the clinical treatment of a single patient. See GUIDANCE Expanded Access for detailed information.
Drugs: Emergency use means that there is not sufficient time to obtain standard IRB review and approval before the drug must be used. UW and FHCC define this as less than seven business days. The drug division of the FDA does not recognize the concept of compassionate use. If the use is not an emergency, then the treating physician is required to obtain standard IRB review and approval (like a research study) before using the drug. Prior FDA approval and Investigational Drug Exemption (IND) are required in emergency and non-emergency situations.
Devices: Emergency use means that there is not sufficient time to use existing procedures to obtain FDA approval (Investigational Device Exemption, or IDE) before the device must be used. Compassionate use means that the use does not meet the criteria for emergency use, and therefore prior FDA approval (IDE) is required before the device can be used. Prospective standard IRB review and approval (like a research study) is not required for emergency or compassionate use.
Are these also the procedures for using a Humanitarian Use Device (HUD)?
A HUD is a device that has been approved by the FDA for treatment or diagnosis of a disease or condition that affects fewer than 8,000 individuals per year in the United States. See this list of HUDs that have been approved by the UW IRB for “on-label” clinical use at UW Medicine. The procedures for using a HUD depend upon the purpose and circumstances. See GUIDANCE Humanitarian Use Device for details and submission instructions.
Open the accordion below for version changes to this guidance.
|Version Number||Posted Date||Implementation Date||Change Notes|
|1.1||08.25.2022||08.25.2022||Revise title; revise URL to nest under GUIDANCE Expanded Access; update links to new web guidance on HUDs and Expanded Access|
|1.0||02.18.2017||02.18.2017||Newly posted guidance|
Key words: Expanded access; FDA