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. 2012;9(7):e1001276.
doi: 10.1371/journal.pmed.1001276. Epub 2012 Jul 31.

How does medical device regulation perform in the United States and the European union? A systematic review

Daniel B Kramer  1 , Shuai Xu, Aaron S Kesselheim
Affiliations

How does medical device regulation perform in the United States and the European union? A systematic review

Daniel B Kramer et al. PLoS Med. 2012.

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 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.

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Conflict of interest statement

DBK is a consultant to Circulatory Systems Advisory Panel of the Food and Drug Administration. SX reports being an inventor on three patent applications related to medical devices, but none of these devices are approved or under review or have applications pending to the FDA or any other regulatory agency. SX also reports being employed by Blue Box Health (until he started medical school in 2009), a closely held medical device company. He holds ex-employee stock options in this company (which has no device currently approved or under review or application pending before the FDA), but has no connection with the company or knowledge of its future plans. The authors declare that no other competing interests exist.

Figures

Figure 1
Figure 1. PRISMA schematic of systematic review search process.
See this image and copyright information in PMC

Comment in

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