This document is used by physicians to:
- Determine and document whether the circumstances in which they hope to make emergency clinical use of an investigational device meets the FDA requirements for emergency use;
- Guide them through the procedures required by the FDA and the UW for emergency use; and
- Notify the IRB of the emergency use within 5 business days after the use.
Revise instructions for chair signature – 06.26.2020
Revised instructions to describe email submission process – 03.12.2020
Updated contact information – 04.14.2017