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 even though the use of a HUD is usually not research. 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.
Permission to use a HUD at Banner-University Medicine must seek IRB approval from the Banner Health Institutional Review Board (IRB). Please contact the appropriate person below for questions about IRB approval for use of a HUD at the Phoenix site.
Robert Flynn - email@example.com or 480-412-6859 (for questions about operational considerations)
Jenny Maxon - firstname.lastname@example.org or 602-839-5777 (for questions about IRB submission)
Please see Banner Health’s policy regarding HUDs here.
Food and Drug Administration's (FDA) FAQ about Medical Devices
Food and Drug Administration (FDA) Podcast "IRBs and Humanitarian Use Device"