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