Guidance for Industry and FDA Staff - Humanitarian Use Device (HUD) Designations
The Food and Drug Administration (FDA) is announcing the availability of a guidance for the industry and FDA staff entitled "Humanitarian Use Device (HUD) Designations." Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. Devices that receive HUD designations may be eligible for marketing approval under the Humanitarian Device Exemption (HDE) marketing pathway. This guidance document is intended to assist applicants in the preparation and submission of HUD designation requests and FDA reviewers in evaluating such requests.
Topics addressed in this guidance include: (1) demonstrating in HUD designation requests that the device is designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year; (2) how this demonstration varies depending on whether the device is intended for therapeutic or diagnostic purposes; (3) how properties of the device may affect this demonstration; and (4) for the purpose of a HUD designation request, delineating an “orphan subset” of persons with a given disease or condition that affects or is manifested in 4,000 individuals or more in the United States per year.
Devices that receive HUD designation may be eligible for marketing approval under an HDE application. An HDE application is a premarketing application that is similar to a premarket approval (PMA) application in that the applicant must demonstrate a reasonable assurance of safety, but in an HDE application, the applicant seeks an exemption from the PMA requirement of demonstrating a reasonable assurance of effectiveness. A device that has received HUD designation is eligible for HDE approval if, among other criteria, the device will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.
Mr. Eric Chen
Director, HUD Designation Program