A Humanitarian Use Device (HUD) is designed for a condition affecting how many individuals in the U.S. annually?

A Humanitarian Use Device (HUD) is specifically intended for the treatment or diagnosis of diseases or conditions that affect fewer than 8,000 individuals in the United States annually. This designation is important as it acknowledges the need for medical devices that target rare diseases, which might otherwise lack sufficient financial incentive for development due to the limited patient population. By establishing the threshold at 8,000, it ensures that devices addressing rare conditions can receive expedited pathways for approval and access, ultimately benefiting patients who might have limited treatment options.

The other options suggest higher annual incidences, which do not align with the established definition of a HUD. For effective research and development of treatments for rare conditions, it is critical to adhere to this specific guideline.