Research > Institutional Review Board (IRB) > Humanitarian Use Device (HUD)

Humanitarian Use Device (HUD)

A Humanitarian use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals per year in the United States. An investigator, or sponsor may submit a request for HUD designation to the FDA, and must include the following information: A statement that the applicant is requesting HUD designation for a rare disease or condition, the name and address of the applicant, a description of the rare disease or condition for which the device is to be used, a description of the device, and documentation with authoritative reference appended, to demonstrate that the device is designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 people in the United States per year. Once approved, this device must be stored separately from all other devices.

Please review the Humanitarian Use Devices Guideline and the Humanitarian Use Devices (HUD) FDA Training Module.

NOTE: An Administrative Review Application is not required for Humanitarian Use Device (HUD) submissions.