UW Research

Forms and Templates

Compassionate Use, Device Notification


If this is an emergency: Do not use this document. Instead use the INSTRUCTIONS and NOTIFICATION Emergency Use, Device.

This document is used by physicians to:

  1. Determine and document whether the circumstances in which they hope to make clinical use of an investigational device meets the FDA requirements for compassionate use;
  2. Guide them through the procedures required by the FDA and the UW for compassionate use; and
  3. Notify the IRB of the compassionate 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
Revised instructions to describe email submission and chair signature process – 06.26.2020
Updated contact information – 4.14.2017