Safe Medical Devices for Children (2006) / Chapter Skim
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References
References
Pages 250-278
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2004. Statement for the Committee on Postmarket Surveillance of Pediatric Medical Devices, Washington, DC.
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2004a. AMA Provides Outline for Developing Na tional Clinical Trials Registry.
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Clinical Trials. [Online]
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2004. Panel discussion before the Committee on Postmarket Surveillance of Pedi atric Medical Devices, Washington, DC.
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Medicare Coverage -- Clinical Trials: Provider Bulletin. [Online]
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2003. Registering clinical trials.
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1990. Council Directive 90/385/EEC of 20 June 1990 on the Approxi mation of the Laws of the Member States Relating to Implantable Medical Devices.
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1996c. Statistical Guidance for Clinical Trials of Non-Diagnostic Medical Devices.
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1999a. A Device Clinical Trials Data Bank -- Public Health Need and Impact on Indus try: A Report to Congress.
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2002h. Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions.
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2002m. Medical Devices; Apnea Monitor; Special Controls.
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2003m. Home Health Care Medical Devices: Blood Glucose Meters - Getting the Most Out of Your Meter.
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2004t. Medical Devices and Radiological Health Fiscal Year 2005.
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1985. Fundamentals of Clinical Trials.
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. Presentation to the Committee on Postmarket Surveillance of Pediatric Medical Devices, Washington, DC.
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. Comments before the Committee on Postmarket Surveillance of Pediatric Medical Devices, Washington, DC, Institute of Medicine.
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2000a. Extending Medicare Reimbursement to Clinical Trials.
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In Press. Databases for studying the epidemiology of implanted medical devices.
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re: 2004N-0254 Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children; Request for Comments. [Online]
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1998. Beyond CONSORT: Need for improved reporting standards for clinical trials.
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. Panel Discussion before the Committe on Postmarket Surveil lance of Pediatric Medical Devices, Washington, DC.
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1984. Federal Policies and the Medical Device Industry.
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1993. Statistical and ethical issues in monitoring clinical trials.
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1996. Do It By Design: An Introduction to Human Factors in Medical Devices.
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2004. Public registration of clinical trials.
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2003. Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy.
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. Medical Devices, Hearing before the Subcommittee on Public Health and the Envi ronment.
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278 SAFE MEDICAL DEVICES FOR CHILDREN Zarins C, Bloch D
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