Humanitarian Use Devices
A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.
To obtain approval for an HUD, a humanitarian device exemption (HDE) application is submitted to FDA. The application must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury and that the probable benefit to health 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. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market. Please see the FDA’s Humanitarian Devices Exemptions (HDE) page.
An approved HDE authorizes marketing of the HUD. However, an HUD may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of devices and after an IRB has approved the use of the device to treat or diagnose the specific disease. Informed consent is required from a patient prior to the use of an HUD. Please see the consent template below.
If IRB approval cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be administered without prior approval by the IRB. In such a situation, the HDE holder shall provide written notification to the IRB Chair within 5 days after the use of the device. Such notification should include the identification of the patient, the date on which the device was used, and the reason for use.
The consent form used for Humanitarian Use Devices can be found on our Templates & Forms page.
Note: All investigators will need to gain access to ePAS in order to submit through the electronic system. Click here for instructions on how to gain access.
ePAS Submissions and Review Processes