Humanitarian Use Device (HUD)

A Humanitarian Use Device (HUD) is a medical device designed to diagnose or treat a disease or condition affecting fewer than 8,000 individuals in the United States annually. Although the FDA has approved its use, the device’s effectiveness may not yet be fully demonstrated at the time of approval.

Requirements for a HUD:

• Target population: It must be intended to treat or diagnose a condition affecting fewer than 8,000 individuals in the U.S. per year.
• Risk: It should not expose patients to significant or unreasonable risk.
• Benefit-risk balance: The benefits of the device must outweigh the risks associated with its use.
• Availability: The device must be unique in that there are no comparable devices currently available.

HUDs are typically used in facilities that are overseen by an Institutional Review Board (IRB). The IRB ensures patient rights and well-being by reviewing the device’s safety and determining the necessary information patients should receive about the HUD’s safety and effectiveness.

Because HUDs cater to a small patient population, the cost of research and development can be high relative to market returns. To encourage companies to develop these devices, HUD regulations offer incentives, such as an expedited approval process with fewer requirements.