Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff

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Technology Humanitarian Device Exemption Medical device Investigational Device Exemption Federal Food Drug and Cosmetic Act Premarket approval Title 21 of the Code of Federal Regulations Center for Biologics Evaluation and Research Medicine Food and Drug Administration Health		Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff Add to Reading List Source URL: www.fda.gov Download Document from Source Website File Size: 112,91 KB Share Document on Facebook

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