How does medical device regulation perform in the United States and the European union? A systematic review.

<h4>Background</h4>Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device...

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Bibliographic Details
Main Authors: Daniel B Kramer, Shuai Xu, Aaron S Kesselheim
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2012-01-01
Series:PLoS Medicine
Online Access:https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1001276&type=printable
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