UW Research
Emergency Use, Device Notification
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.
Change Notes
Add steps for Billing Compliance and OSP Expanded Access Agreements – 03.27.2025
Updated email address to hsdreprt for requests for manufacturer letters; other updates to instructions – 02.01.2024
Shift all HSD staff responsibilities to Regulatory Affairs team – 01.26.2023
Retitle; transfer content from PDF to Word; moderate reorganization and revision to content – 08.25.2022
Revise instructions for chair signature – 06.26.2020