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

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 regulation in these settings.We...

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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:http://europepmc.org/articles/PMC3418047?pdf=render