Department of Health and Human Services July 8, 2010 – Federal Register Recent Federal Regulation Documents
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Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Humanitarian Device Exemption Regulation; Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Humanitarian Device Exemption (HDE) Regulation: Questions and Answers.'' This guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and applications for HDEs.
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