Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations; Availability

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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. This guidance finalizes the draft guidance of the same title dated December 2011.