Humanitarian use devices (HUDs) are a special class of device approved by the FDA for use in a rare condition (manifesting in fewer than 4,000 persons per year). The FDA allows the manufacture and use of HUDs without the same efficacy data for other FDA approved devices due to the small number of individuals impacted. A Humanitarian Device Exemption (HDE) is issued by the FDA, and an approved HDE authorizes the marketing of a HUD.
A device that has received HUD designation is eligible for FDA approval if, among other criteria, the device will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.
The FDA requires that HUDs receive approval and ongoing monitoring from an IRB.
New HUD requests
Effective July 2016, studies requesting permission to use a HUD at Banner-University Medicine must seek IRB approval from the Banner Health Institutional Review Board (IRB).
Banner- University Medical Center Tucson: Please contact Derek Shemley (firstname.lastname@example.org or 520-694-5552) for for questions about IRB approval for use of a HUD at Tucson Site.
Banner- University Medical Center Phoenix: Please contact the appropriate person below for questions about IRB approval for use of a HUD at the Phoenix site.
Cardiology: Ann Coombs - email@example.com or 970-810-2012
Neurology: Robert Flynn - firstname.lastname@example.org or 602-839-6846
Other: Mandy Childs - email@example.com or 602-839-3207
Please see Banner Health’s policy regarding HUDs here.
If a HUD will be studied in a research project, then an application for approval of human research should be submitted to the UA IRB. Please submit the F200, Application for human research, along with the necessary attachments for review to the UA IRB.
The Forms on this page are for EXISTING HUDs opened by the UA IRB prior to July 2016.
F221: Continuing Review Progress Report for Humanitarian Use Device (HUD) (Word)
This form is used for both continuing review and as a final report for studies using Humanitarian Use Devices.
F222: Modifications of Approved Humanitarian Use Device (HUD) (Word)
Submit this form to the IRB if you are making a modification to a previously approved Application for Humanitarian Use Device (HUD).
C104: HUD Responsibilities and Checklist (Word)
Outlines the responsibilities of physicians, IRBs, and Humanitarian Device Exemption (HDE) holders.
Food and Drug Administration's (FDA) FAQ about Medical Devices
Food and Drug Administration (FDA) Podcast "IRBs and Humanitarian Use Device"