Medical Devices; Humanitarian Use Devices

This ICR collects information from manufactures who wish to obtain "Humanitarian Use Device" (HUD) designation for a medical device and marketing approval for the HUD notwithstanding the absence of reasonable assurance of effectiveness that would otherwise be required. To the extent consistent with the protection of the public health and safety and with ethical standards, this program encourages the discovery and use of devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in fewer than 4,000 individuals in the United States per year. Obtaining marketing approval for a HUD involves two steps: (1) Obtaining designation of the device as a HUD from FDA's Office of Orphan Products Development and (2) submitting a Humanitarian Device Exemption (HDE) application to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), or the Center for Drug Evaluation and Research (CDER), as applicable. A person granted an exemption must submit periodic reports.

The latest form for Medical Devices; Humanitarian Use Devices expires 2021-03-31 and can be found here.