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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 07/25/2014
Version 1.30
Filesize 70.95 KB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Policy

SOP Humanitarian Use Device

Purpose

This document describes the policies and procedures about medical devices that have been classified by the Food and Drug Administration (FDA) as humanitarian use devices (HUDs).

Related Documents

Change Notes

  • Related to Ver. 1.30, noted 07/25/2014 @ 11:22am
    Clarity about use of confintuing review.
    - sherrye
  • Related to Ver. 1.20, noted 05/30/2014 @ 09:51am
    Additional UW Medicine requirement adde: 5.7
    - sherrye
  • Related to Ver. 1.10, noted 03/14/2014 @ 02:25pm
    Removed language that had been stricken from the document.
    - sherrye
  • Related to Ver. 1.00, noted 11/27/2013 @ 02:18pm
    Document newly added.
    - sherrye