how does medical device regulation perform in the united states and the european union a systematic review医疗器械监管如何执行在美国和欧盟系统回顾.pdfVIP

How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review 1,2 1 1,3 Daniel B. Kramer *, Shuai Xu , Aaron S. Kesselheim 1 Harvard Medical School, Boston, Massachusetts, United States of America, 2 Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America, 3 Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, United States of America Abstract 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 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 submis