ࡱ> BDA `bjbj}} .$: %0008h,0%.LL%(T%V%V%V%V%V%V%$')z%MMMz%%MRT%MT%ZnF@%%0%,I*HI*I*(MMMMMMMz%z%-lMMM%MMMMI*MMMMMMMMM : 91Ů Institutional Review Board GUIDELINES FOR HUMANITARIAN USE DEVICE (HUD) SUBMISSIONS Definitions 1. What is a Humanitarian Use Device (HUD)? The definition of a HUD is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or are manifested in fewer than 4,000 individuals in the United States per year. 2. What is a Humanitarian Device Exemption (HDE)? A Humanitarian Device Exemption (HDE) is an application that is similar to a pre-market approval (PMA) application. An approved HDE authorizes marketing of a Humanitarian Use Device (HUD). B. Additional Resources For more information about HUD or HDE, see the following links: Q&A  HYPERLINK "http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110194.htm" http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110194.htm General information  HYPERLINK "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm" http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm C. IRB Review Process Because the 91Ů IRB must conduct an initial review and continuing reviews of humanitarian use device submissions, 91Ů clinicians will need to complete the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hud_application.doc"Humanitarian Use Device Submission Form. HUD Applications are initially reviewed at the convened board, but continuing reviews can be done through expedited review. Because the submission is for a HUD and not for a clinical investigation, you should not refer to it as "research" in your application. Please provide the manufacturer's materials (e.g., protocol, device information) and include any information that would be helpful to the IRB reviewers as instructed by the HUD Application. Although the FDA regulations do not require a consent form, 91Ů IRB does require that consent be obtained and that the proposed consent form be reviewed by the Board. For guidance, please refer to the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hud_consent_form.doc"HUD consent form template. Please submit a copy with your application or provide a justification for waiver of consent in the IRB Application. Assent from minors is typically not required given that this is treatment and parents typically make those decisions for minor children.     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