UW Research

Policies, Procedures and Guidance

SOP Humanitarian Use Device


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).

Change Notes

Updated HUD definition per FDA – 02.25.2021
Removed all references to Confidentiality Agreements and to state law RCW 42.48 – 07.28.2019
RE use of HUD: clarified the importance of whether the UW IRB has approved its use, and that it doesn’t matter whether it is being used on-label or off-label. – 05.07.2018
Updated links – 07.26.2017