What defines a Humanitarian Use Device (HUD)?

A Humanitarian Use Device (HUD) is specifically defined by its intent to treat conditions that affect a small population. More precisely, a HUD is intended for patients who have conditions that affect fewer than 8,000 individuals in the United States annually. This definition is important as it reflects the legislative and regulatory framework established to ensure that medical devices can be developed and brought to market to address unmet medical needs for rare diseases or conditions, thus promoting innovation while still adhering to patient safety standards.

The option regarding prevalent diseases addresses more common health issues, which does not align with the definition of HUDs intended for rare conditions. The option that states a device does not require FDA approval is misleading, as HUDs do require FDA approval, albeit through a different, more streamlined pathway than traditional devices. Lastly, the notion that a device is used exclusively for research purposes does not accurately capture the intent of HUDs, which are utilized in clinical settings to provide therapeutic options to patients with rare conditions. Thus, the definition focusing on conditions affecting under 8,000 individuals annually accurately encapsulates the purpose and regulatory attention surrounding Humanitarian Use Devices.