Regulation of Medical Devices in the United States and European Union

The New England Journal of Medicine: Daniel B. Kramer, M.D., Shuai Xu, M.Sc., and Aaron S. Kesselheim, M.D., J.D., M.P.H., N Engl J Med 2012; 366:848-855 – March 1, 2012.

Millions of patients worldwide depend on an ever-widening array of medical devices for the diagnosis and management of disease. In the United States, the Food and Drug Administration (FDA) requires manufacturers of high-risk devices such as heart valves and intraocular lens implants to demonstrate safety and effectiveness before the devices can be marketed. However, some policymakers and device manufacturers have characterized U.S. device regulation as slow, risk-averse, and expensive.1,2 Other experts, such as those at the Institute of Medicine, have suggested that current premarketing procedures may not be comprehensive enough and may be particularly dangerous for devices that have been cleared by the FDA on the basis of substantial similarity to an already marketed device.3

A frequent point of comparison for device regulation in the United States is regulation in the European Union.4-6 Reports suggest that European patients have access to some high-risk medical devices, such as coronary stents and replacement joints, earlier than American patients. This system has been touted as being better for patient care,7 as well as supporting good-paying jobs and a positive trade balance.8However, the E.U. system has drawn criticism for conflicts of interest in its evaluation process,9 and a recent recall of a popular silicone breast implant that was approved only in the European Union has reinforced European concerns about the clinical evaluation of high-risk devices.10-12

As policymakers in the United States and Europe weigh these critiques, it is an opportune time to compare the two systems and consider what evidence exists on the performance of each device-approval system. Read More