Humanitarian Device Exemption (HDE)

The Humanitarian Device Exemption (HDE) is a regulatory pathway by the U.S. Food and Drug Administration (FDA) that allows manufacturers to get approval for medical devices intended to treat or diagnose rare conditions affecting fewer than 8,000 people per year in the U.S. The HDE process requires evidence that the device is safe and likely effective, but it does not require the same level of extensive testing as other approvals. This pathway helps provide patients with limited options access to innovative devices for conditions where traditional research may be difficult or limited due to the small patient population.