Abstract
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. 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. 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.
Highlights
As medical devices play a growing role in the diagnosis and management of disease, the global medical device industry has surpassed United States (US)$350 billion in annual revenue [1]
Existing studies of US and European Union (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
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
Summary
As medical devices play a growing role in the diagnosis and management of disease, the global medical device industry has surpassed US$350 billion in annual revenue [1]. New devices have posed substantial risks to patients, with high-profile recalls in recent years affecting breast implants [2], specific types of artificial hips [3], devices for lung surgery [4], and implantable cardioverter-defibrillator leads [5] These episodes have led experts to call for greater pre-market testing for safety and effectiveness of new devices and monitoring of their performance after approval [6,7]. Some case reports suggested substantial dangers to patients in the EU from devices approved on the basis of limited data, but the researchers could not systematically compare the quality of studies used for device approval or post-approval safety outcomes between the EU and US, mainly because of the lack of transparency among the EU regulators (Notified Bodies)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
