For a device to qualify for an HDE, several criteria must be met: 1. The device must be intended for a condition that affects fewer than 8,000 individuals in the U.S. per year. 2. The device must not pose an unreasonable or significant risk of illness or injury. 3. There must be no other comparable device available to treat or diagnose the condition. 4. The probable benefit to health from using the device must outweigh the risk of injury or illness from its use.
