Forms and Templates

INSTRUCTIONS and NOTIFICATION Compassionate Use, Device

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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

Revised instructions to describe email submission and chair signature process – 06.26.2020
Updated contact information – 4.14.2017