Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.

Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.

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http://www.wikidata.org/entity/Q43785105
How does medical device regulation perform in the United States and the European union? A systematic reviewLeft to their own devices: breakdowns in United States medical device premarket review.Approval of high-risk medical devices in the US: implications for clinical cardiologyFDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.Medical device assessment: scientific evidence examined by the French national agency for health - a descriptive studyContrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments.Medical device postapproval safety monitoring: where does the United States stand?Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis.Meta-Review of the Quantity and Quality of Evidence for Knee Arthroplasty DevicesHow do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.Enrollment and monitoring of women in post-approval studies for medical devices mandated by the Food and Drug Administration.Pre-market clinical evaluations of innovative high-risk medical devices in Europe.Regulatory science: Trust and transparency in clinical trials of medical devices.The association of robotic surgical technology and hospital prostatectomy volumes: increasing market share through the adoption of technology.
P2860

Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.

Item
http://www.wikidata.org/entity/Q43785105
description
2010 nî lūn-bûn
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2010年の論文
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2010年学术文章
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Premarket clinical evaluation ...... Drug Administration 2000-2007.
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Premarket clinical evaluation ...... Drug Administration 2000-2007.
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Premarket clinical evaluation ...... Drug Administration 2000-2007.
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Premarket clinical evaluation ...... Drug Administration 2000-2007.
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Premarket clinical evaluation ...... Drug Administration 2000-2007.
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Premarket clinical evaluation ...... Drug Administration 2000-2007.
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Premarket clinical evaluation ...... Drug Administration 2000-2007.
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10.1097/MJT.0B013E3181CA8105
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