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医疗器械监管：提高效能势在必行。

Medical device regulation: time to improve performance.

机构信息

Division of Cardiovascular Medicine, Davis Medical Center, University of California, Sacramento, California, United States of America.

出版信息

PLoS Med. 2012;9(7):e1001277. doi: 10.1371/journal.pmed.1001277. Epub 2012 Jul 31.

DOI:10.1371/journal.pmed.1001277
PMID:22859912
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3409121/
Abstract

Sanket Dhruva and Rita Redberg comment on a research study evaluating the evidence regarding the performance of device regulatory systems. They argue that adequate funding and increased transparency are vital to future reform.

摘要

桑克特·德鲁瓦和丽塔·雷德伯格就一项评估设备监管系统性能的研究发表评论。他们认为，充分的资金和提高透明度对于未来的改革至关重要。

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本文引用的文献

1
How does medical device regulation perform in the United States and the European union? A systematic review.美国和欧盟的医疗器械监管表现如何？一项系统评价。
PLoS Med. 2012;9(7):e1001276. doi: 10.1371/journal.pmed.1001276. Epub 2012 Jul 31.
2
Medical device recalls and transparency in the UK.英国的医疗器械召回与透明度
BMJ. 2011 May 13;342:d2973. doi: 10.1136/bmj.d2973.
3
Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.心血管器械的临床评估：欧洲监管改革的原则、问题和建议。欧洲心脏病学会政策会议报告。
Eur Heart J. 2011 Jul;32(13):1673-86. doi: 10.1093/eurheartj/ehr171. Epub 2011 May 14.
4
Medical device recalls and the FDA approval process.医疗器械召回与美国食品药品监督管理局（FDA）的审批流程。
Arch Intern Med. 2011 Jun 13;171(11):1006-11. doi: 10.1001/archinternmed.2011.30. Epub 2011 Feb 14.
5
Reviving the FDA.重振美国食品药品监督管理局。
N Engl J Med. 2010 Oct 14;363(16):1492-4. doi: 10.1056/NEJMp1009686. Epub 2010 Oct 6.
6
Left to their own devices: breakdowns in United States medical device premarket review.放任自流：美国医疗器械上市前审查的崩溃。
PLoS Med. 2010 Jul 13;7(7):e1000280. doi: 10.1371/journal.pmed.1000280.
7
The need for improved access to FDA reviews.改善获取美国食品药品监督管理局审评结果的需求。
JAMA. 2009 Jul 8;302(2):191-3. doi: 10.1001/jama.2009.973.
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Learning from our mistakes? Testing new ICD technology.从错误中学习？测试新的植入式心脏除颤器技术。
N Engl J Med. 2008 Dec 11;359(24):2517-9. doi: 10.1056/NEJMp0805359.