federal_register: 2011-31867

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2011-31867 Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled "Humanitarian Use Device (HUD) Designations."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 designation 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. 2011-12-13 2011 12 https://www.federalregister.gov/documents/2011/12/13/2011-31867/draft-guidance-for-industry-and-food-and-drug-administration-staff-on-humanitarian-use-device https://www.govinfo.gov/content/pkg/FR-2011-12-13/pdf/2011-31867.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled "Humanitarian Use Device (HUD) Designations." Devices are eligible for HUD designation if they are designed to treat or...

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