CDRH Update: Federal Register: Humanitarian Device Exemption Regulation: Draft Guidance for Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Questions and Answers

Draft Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Humanitarian Device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.

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