This guidance describes the circumstances regarding Emergency Use of an investigational product (drug, biologic, or device) and the procedures to be followed before or immediately following the emergency use of an investigational product.
Emergency Use is a form of Expanded Access and is part of the FDA Expanded Access program. For non-emergency use and additional information, see also the IRBMED Expanded Access guidance page.
Emergency use is defined at 21 CFR 56.102(b)(d) as
- the use of a test article (drug, biologic, or device)
- on a human subject in a life-threatening situation
- in which no standard acceptable treatment is available, and
- in which there is not sufficient time to obtain IRB approval.
The expanded access emergency use provisions in the FDA regulations, 21 CFR 56.104(c), provide
- an exemption from prior review and approval by the IRB, as long as
- the emergency use is reported to the IRB within five working days.