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Humanitarian Device Exemption
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91	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Investigational Device Exemption Federal Food Drug and Cosmetic Act Medical device Center for Devices and Radiological Health Genetic testing Humanitarian Device Exemption Food and Drug Administration Modernization Act Food and Drug Administration Medicine Health
92	Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff Add to Reading List Source URL: www.fda.gov Language: English 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
93	WAIVER OF INFORMED CONSENT IN RESUSCITATION RESEARCH: HOW CAN PATIENTS’ RIGHTS BE PROTECTED? Add to Reading List Source URL: www.fda.gov Language: English Health Premarket approval Center for Devices and Radiological Health Humanitarian Device Exemption Medical device HUD Title 21 of the Code of Federal Regulations Investigational Device Exemption Food and Drug Administration Medicine Technology
94	Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff Add to Reading List Source URL: www.fda.gov Language: English 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
95	Federal Register / Vol. 79, No. 7 / Friday, January 10, [removed]Rules and Regulations solely to the agency’s organization, procedure, or practice. Accordingly, the provisions of the Administrative Procedure Act regardin Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2014-01-10 00:30:54 Technology Federal Food Drug and Cosmetic Act Premarket approval Medical device Center for Devices and Radiological Health Humanitarian Device Exemption Title 21 CFR Part 11 Off-label use Food and Drug Administration Medicine Health
96	JAMA PATIENT PAGE \| Health Policy FDA Authorization of Medical Devices Similar to drugs, medical devices in the United States go through a review process by the US Food and Drug Administration (FDA) before they can be m Add to Reading List Source URL: jama.jamanetwork.com Language: English Technology Investigational Device Exemption Premarket approval Center for Devices and Radiological Health Medical device Clinical trial Humanitarian Device Exemption Clinical research New Drug Application Food and Drug Administration Medicine Health
97	Institutional Review Boards and Humanitarian Use Device (HUD) Presented by Fabienne Santel, MD Division of Bioresearch Monitoring Office of Compliance Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Clinical research Humanitarian Device Exemption Food law Premarket approval Institutional review board Title 21 of the Code of Federal Regulations Center for Devices and Radiological Health Food and Drug Administration Medicine Pharmacology
98	Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff Add to Reading List Source URL: www.fda.gov Language: English Technology Food law Pharmaceuticals policy Clinical research Pharmacology Humanitarian Device Exemption Premarket approval Federal Food Drug and Cosmetic Act Medical device Food and Drug Administration Medicine Health
99	Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Investigational Device Exemption Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Medical device Humanitarian Device Exemption Center for Biologics Evaluation and Research Food and Drug Administration Medicine Health
100	Institutional Review Board Add to Reading List Source URL: research.uthscsa.edu Language: English - Date: 2011-05-24 10:51:18 Research Pharmaceutical sciences Medicine Pharmaceutical industry Design of experiments Institutional review board Humanitarian Device Exemption United States Department of Housing and Urban Development Premarket approval Clinical research Food and Drug Administration Pharmacology

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