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How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

BACKGROUND: 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...

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Autori principali: Kramer, Daniel B., Xu, Shuai, Kesselheim, Aaron S.
Natura: Artigo
Lingua:Inglês
Pubblicazione: Public Library of Science 2012
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Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC3418047/
https://ncbi.nlm.nih.gov/pubmed/22912563
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1371/journal.pmed.1001276
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