Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff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 Premarket approval Federal Food Drug and Cosmetic Act Institutional review board Title 21 of the Code of Federal Regulations Center for Biologics Evaluation and Research Food and Drug Administration Medicine Health		Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff Add to Reading List Source URL: www.fda.gov Download Document from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: 326,91 KB Share Document on Facebook

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