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J Interv Card Electrophysiol. 2013 Mar;36(2):99-105. doi: 10.1007/s10840-012-9767-1. Epub 2012 Dec 21.

FDA regulation of cardiovascular devices and opportunities for improvement.

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  • 1Department of Internal Medicine, Division of Cardiology, University of California, Davis, CA, USA.


Medical devices are of increasing importance in cardiovascular disease and have made important contributions to patient care. These devices continue to evolve with increasing complexity. FDA regulation of medical devices involves increased stringency for higher risk and novel devices. However, there are some current opportunities to strengthen the FDA's pre-approval regulatory process and improve post-marketing surveillance. This article reviews FDA regulation of cardiovascular devices and offers suggestions for strengthening the process while focusing on examples relevant to cardiac electrophysiologists.

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