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dc.contributor.authorKramer, Daniel Bruce
dc.contributor.authorXu, Shuai
dc.contributor.authorKesselheim, Aaron Seth
dc.date.accessioned2013-03-27T17:42:56Z
dc.date.issued2012
dc.identifier.citationKramer, Daniel B., Shuai Xu, and Aaron S. Kesselheim. 2012. How does medical device regulation perform in the United States and the European Union? A systematic review. PLoS Medicine 9(7): e1001276.en_US
dc.identifier.issn1549-1277en_US
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:10471502
dc.description.abstractBackground: 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. Methods and Findings: We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. Conclusions: Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting.en_US
dc.language.isoen_USen_US
dc.publisherPublic Library of Scienceen_US
dc.relation.isversionofdoi:10.1371/journal.pmed.1001276en_US
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3418047/pdf/en_US
dash.licenseLAA
dc.subjectMedicineen_US
dc.subjectClinical Research Designen_US
dc.subjectSystematic Reviewsen_US
dc.subjectDrugs and Devicesen_US
dc.subjectMedical Devicesen_US
dc.subjectNon-Clinical Medicineen_US
dc.subjectHealth Care Policyen_US
dc.subjectGeographic and National Differencesen_US
dc.subjectHealth Systems Strengtheningen_US
dc.subjectSocial and Behavioral Sciencesen_US
dc.subjectLawen_US
dc.subjectFederal Lawen_US
dc.titleHow Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Reviewen_US
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden_US
dc.relation.journalPLoS Medicineen_US
dash.depositing.authorKesselheim, Aaron Seth
dc.date.available2013-03-27T17:42:56Z
dc.identifier.doi10.1371/journal.pmed.1001276*
dash.contributor.affiliatedKramer, Daniel
dash.contributor.affiliatedXu, Shuai
dash.contributor.affiliatedKesselheim, Aaron


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