Emergency use

21 CFR 56 allows such a use without prior IRB approval, but it must be reported to the IRB within 5 working days, and any later use needs IRB review. It is a different concept from an Emergency Use Authorization (EUA).

Emergency use means the use of a test article 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.

21 CFR, 56.102