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Title: RR 405 Humanitarian Use Device HUD/HDE Department: Sparrow Institutional Review Board 1.0 Policy: The FDA requires the IRB to approve the use of a Humanitarian Use Device (HUD) to treat or
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Title RR 405 Humanitarian refers to the specific regulation pertaining to humanitarian assistance activities.
Organizations or individuals involved in humanitarian activities are required to file Title RR 405 Humanitarian.
Title RR 405 Humanitarian can be filled out by providing detailed information on the humanitarian activities being conducted.
The purpose of Title RR 405 Humanitarian is to ensure transparency and accountability in humanitarian assistance efforts.
Information such as the nature of humanitarian activities, locations served, beneficiaries, and funding sources must be reported on Title RR 405 Humanitarian.
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Relevant keywords

IRB HDE RR FDA CFR 405-B 405-A IRRC IRBNet 401-Expedited 403-B FDAs reportable 403-A designee dissemination Contraindications acknowledgements Chairperson Identifier deems expedited designation noncompliance submissions labeling SOP regulatory utilized In

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