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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 07/25/2014
Version 1.20
Filesize 2.2 MB
Audiences IRB Member, Researcher
Doc Type Form
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INSTRUCTIONS and NOTIFICATION: Compassionate Use, Device

Purpose

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 days after the use.

Change Notes

  • Related to Ver. 1.20, noted 07/25/2014 @ 10:49am
    Added note regarding authorizationi from the FDA - You may be required to provide the opinion of an appropriate uninvolved physician that the use of the device is necessary and approrpiate. Use this version going forward.
    - sherrye
  • Related to Ver. 1.10, noted 05/30/2014 @ 09:48am
    Added box for UW Department or Division.
    - sherrye
  • Related to Ver. 1.00, noted 02/28/2014 @ 09:04am
    Document newly added.
    - sherrye