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Investigational Device Exemption
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71	21st Century Cures Legislation Discussion Draft: Key Provisions Related to Medical Devices February 4, 2015 Food & Drug Add to Reading List Source URL: www.cov.com Language: English - Date: 2015-02-04 15:28:27 Clinical research Research Pharmaceutical industry Pharmacology Medical statistics Medical device Investigational Device Exemption Federal Food Drug and Cosmetic Act Premarket approval Food and Drug Administration Medicine Health
72	SUNY Upstate Medical University Institutional Review Board EMERGENCY USE OF UNAPPROVED MEDICAL DEVICES (From FDA Information Sheets) Add to Reading List Source URL: www.upstate.edu Language: English - Date: 2011-03-08 09:40:52 Clinical research Research Pharmacology Food law Pharmaceutical industry Investigational Device Exemption Institutional review board Medical device Center for Devices and Radiological Health Medicine Health Food and Drug Administration
73	Microsoft Word - INFORMED CONSENT GUIDANCE[removed]DRAFT_EBF_.DOC Add to Reading List Source URL: www.upstate.edu Language: English - Date: 2009-12-11 15:25:24 Pharmacology Ethics Pharmaceutical industry Design of experiments Drug safety Institutional review board Investigational Device Exemption Food and Drug Administration Clinical investigator Clinical research Research Science
74	APPENDIX C DEFINITIONS AND ELABORATIONS The definitions and elaborations herein are designed to conform to Title 45 Code of Federal Regulations (CFR) Part 46 as implemented by United States Department of Health and Human Add to Reading List Source URL: www.uco.edu Language: English - Date: 2014-09-12 09:25:52 Medicine Pharmacology Pharmaceutical industry Design of experiments Food and Drug Administration Clinical trial Investigational New Drug Human subject research Investigational Device Exemption Clinical research Research Science
75	Nile J. Boldt, et al. v. Venaxis, Inc., et al. 15-CV[removed]Class Action Complaint for Violation of the Federal Securities Laws and Jury Demand Add to Reading List Source URL: securities.stanford.edu Language: English - Date: 2015-02-05 20:55:15 Research Clinical pharmacology Food and Drug Administration Pharmacology United States Public Health Service Investigational Device Exemption Validation Clinical research Pharmaceutical industry Pharmaceutical sciences
76	IDE DECISION WORKSHEET For Investigator-Initiated Medical Device Clinical Investigations INVESTIGATOR NAME: ________________________________________________________________ INVESTIGATIONAL DEVICE NAME & MANUFACTURER: ___ Add to Reading List Source URL: www.michr.umich.edu Language: English - Date: 2011-10-05 12:23:56 Science Clinical research Pharmaceutical industry Pharmacology Implants Investigational Device Exemption Institutional review board Medical device Clinical trial Medicine Health Food and Drug Administration
77	Review of the ReGen Menaflex®: Departures from Processes, Procedures, and Practices Leave the Basis for a Review Decision in Question Add to Reading List Source URL: www.fda.gov Language: English* Health Pharmaceutical industry Clinical research Center for Devices and Radiological Health Premarket approval Food law Medical device Investigational Device Exemption Title 21 of the Code of Federal Regulations Medicine Food and Drug Administration Technology
78	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-12-30 12:09:50 Health Center for Devices and Radiological Health Unique Device Identification Premarket approval Medical device Federal Food Drug and Cosmetic Act Title 21 of the Code of Federal Regulations Adverse event Investigational Device Exemption Food and Drug Administration Medicine Technology
79	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2015-01-16 15:53:46 Health Medical device Premarket approval Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Unique Device Identification Adverse event Title 21 of the Code of Federal Regulations Investigational Device Exemption Food and Drug Administration Medicine Technology
80	FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmaceutical industry Pharmacology Design of experiments Food and Drug Administration Investigational Device Exemption Clinical trial Institutional review board Medical device Clinical research Research Medicine

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