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Update regarding opportunities for orthopaedic surgeons to contribute to postmarket surveillance of potential safety issues for orthopaedic medical devices marketed in the United States.

作者信息

Devlin Vincent J

机构信息

Division of Orthopedic Devices, Center for Devices and Radiological Health, Office of Device Evaluation, U.S. Food and Drug Administration, Silver Spring, MD, USA.

出版信息

Arthroplast Today. 2017 Oct 16;3(4):205-206. doi: 10.1016/j.artd.2017.09.003. eCollection 2017 Dec.

Abstract
摘要

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本文引用的文献

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An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials.
N Engl J Med. 2017 Apr 6;376(14):1350-1357. doi: 10.1056/NEJMra1512592.
2
Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance.
JAMA. 2017 Feb 21;317(7):693-694. doi: 10.1001/jama.2017.0410.
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Need for a National Evaluation System for Health Technology.
JAMA. 2016 Sep 20;316(11):1153-4. doi: 10.1001/jama.2016.8708.
4
Reporting and notification of adverse events in orthopaedics.
J Am Acad Orthop Surg. 2010 Apr;18(4):193-8. doi: 10.5435/00124635-201004000-00002.

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