Regulation of Medical Devices in the United States and European Union – HEALTH LAW, ETHICS, AND HUMAN RIGHTS: February 14, 2012 (10.1056/NEJMhle1113918), By Daniel B. Kramer, M.D., Shuai Xu, M.Sc., and Aaron S. Kesselheim, M.D., J.D., M.P.H.

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.


United States

The Medical Device Amendments of 1976 gave the FDA primary authority to regulate medical devices and required the FDA to obtain “reasonable assurance of safety and effectiveness” before marketing.13 This legislation has been updated several times, including the Medical Device User Fee and Modernization Act of 2002, which established sponsor user fees for application reviews and set performance targets for review times.14

Each device type is assigned by the FDA into one of three regulatory classes on the basis of its risk and the evaluation necessary to demonstrate safety and effectiveness.15,16 Most class I devices (e.g., stethoscopes) are low-risk and subject only to “general controls,” such as tests of sterility. Class II devices (e.g., computed tomographic scanners) meet general controls as well as “special controls,” such as additional labeling requirements. These moderate-risk devices generally pass through the 510(k) review pathway, which refers to the section of the Food, Drug, and Cosmetic Act dealing with premarket notification. In this process, the FDA and the manufacturer rely on similarities between the device at issue and a previously cleared device. If a manufacturer can show that its device is “substantially equivalent,” additional clinical data are usually not required, although requirements for performance standards and postmarketing surveillance may be imposed. Class III products (e.g., deep-brain stimulators and implantable cardioverter–defibrillators) require clinical studies evaluating the safety and effectiveness of the device, called a Premarket Approval (PMA) application.17 However, class III devices that arise from changes to previously PMA-approved devices may not need additional clinical studies.18,19 In addition, some older class III devices for which the FDA has not specifically called for PMAs can receive clearance through the 510(k) pathway.17 Devices that treat rare disorders (fewer than 4000 patients annually) may receive a Humanitarian Device Exemption and be approved on the basis of “probable” benefits, a more flexible standard that recognizes the difficulty of studying patient populations with small numbers and limited treatment options.20

Sites where cleared or approved devices are used must report related serious adverse events to the FDA and the manufacturer.21,22 These reports are stored in a searchable, publicly available database called Manufacturer and User Facility Device Experience. In addition, the FDA may conduct inspections, require manufacturers of high-risk devices to conduct postapproval studies, and initiate recalls. Read Full Article