Background: Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to\r\ntheir medical device approval and post-market surveillance systems. Data may be available that identify strengths and\r\nweakness of the approaches to medical device regulation in these settings.\r\nMethods and Findings: We performed a systematic review to find empirical studies evaluating medical device regulation in\r\nthe US or EU. We searched Medline using two nested categories that included medical devices and glossary terms\r\nattributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We\r\nsupplemented this search with a review of the US Government Accountability Office online database for reports on US Food\r\nand Drug Administration device regulation, consultations with local experts in the field, manual reference mining of\r\nselected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket\r\nevaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies\r\nprovide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based\r\nlargely on recall data, and relay perceptions of some industry leaders from self-surveys.\r\nConclusions: Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of\r\nUS and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both\r\nsystems, including improving classification of devices in the US and promoting transparency and post-market oversight in\r\nthe EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes.\r\nChanges to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that\r\nthere is better assessment of what works in either setting.\r\nPlease see later in the article for the Editors� Summary.
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