A Humanitarian Device Exemption (HDE) is a regulatory pathway provided by the U.S. Food and Drug Administration (FDA) that allows for the approval of medical devices intended to benefit patients by treating or diagnosing a condition that affects fewer than 8,000 individuals in the United States per year. These are known as Humanitarian Use Devices (HUDs). The HDE process aims to facilitate the availability of devices for rare diseases or conditions, often referred to as orphan conditions.
