Forms and Templates

Emergency Use, Device Notification

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This document is used by physicians to:

1. 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;
2. Guide them through the procedures required by the FDA and the UW for emergency use; and
3. Notify the IRB of the emergency use within 5 business days after the use.

Change Notes

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
Revise instructions to describe email submission process – 03.12.2020