Introduction

A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease that affects fewer than 8,000 individuals in the United States per year. To be considered for HUD status, a device sponsor must complete a humanitarian device exemption (HDE) application with the Food and Drug Administration (FDA). An approved HDE application authorizes the applicant to market the HUD. The labeling for the HUD must state that the device is a HUD and that the effectiveness of the device has not been demonstrated.

Guidance

Before a HUD under an approved HDE can be used for clinical care at the University of Utah or its affiliates, Institutional Review Board (IRB) initial and continuing review is required except in cases of emergency use. Although the use of a HUD is not considered research, FDA regulations require the local IRB to approve and monitor its use.

The IRB review of HUDs can be particularly challenging, given that there is no research objective or design. The primary reason for this requirement may be to give notice to the institution that the HUD will be used. The IRB’s approval for the use of a HUD at a facility to treat or diagnose patients as part of clinical care does not constitute IRB approval of a clinical investigation involving the HUD.

The IRB has the discretion to determine the conditions of HUD use. The IRB may approve the use of the device in general, in a specific number of patients, only under specific circumstances, etc. The regulations require that an IRB conduct both initial and continuing review of an HUD.

A local IRB may defer to another IRB that has agreed to assume responsibility for reviewing the use of the HUD in the setting in question. All inter-IRB agreements must be documented in writing.

The holder of the HDE is responsible for ensuring that the HUD is used only at facilities that have established an IRB that operates in compliance with FDA regulations.

FDA regulations do not require informed consent to use an HUD outside the setting of a research protocol. However, the University of Utah IRB requires that informed consent be obtained for the use of a HUD. The University of Utah HUD Consent Checklist is available for use.

The University of Utah has a specific application for Humanitarian Use Devices (Application for Humanitarian Use Device (HUD) under a Humanitarian Device Exemption) in ERICA.

Documents and References

Humanitarian Device Exemption Program (HDE) Program – FDA

IRB SOP 502: Clinical Research Involving Investigational Drugs and Devices

University of Utah IRB HUD Consent Checklist

Points to Consider