Fillable Humanitarian Use Device Humanitarian Device Exemption - ORC - orc emory

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Humanitarian Use Device Humanitarian Device Exemption Marian Serge, RN Division of Bioresearch Monitoring Center for Devices and Radiological Health Marian.Serge fda.hhs.gov 1 HUD and HDE Topics Regulations/Federal Register/Guidance Distinguish between HUD and HDE IRB responsibilities Physician and HDE-holder responsibilities FDA concerns Revised HDE guidance 2 Humanitarian Use Device and Humanitarian Device...
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