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:
- 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;
- Guide them through the procedures required by the FDA and the UW for compassionate use; and
- Notify the IRB of the compassionate use within 5 business days after the use.
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