A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease that affects fewer than 4,000 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 FDA. An approved HDE application authorizes the applicant to market the HUD. The labeling for the HUD must state that the device is an HUD and that the effectiveness of the device has not been demonstrated.