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Thursday, January 5, 2012

FDA Regulation of Medical Devices

Judith A. Johnson
Specialist in Biomedical Policy

Prior to and since the passage of the Medical Device Amendments of 1976, Congress has debated how best to ensure that consumers have access, as quickly as possible, to new and improved medical devices and, at the same time, prevent devices that are not safe and effective from entering or remaining on the market. Medical devices regulation is complex, in part, because of the wide variety of items that are categorized as medical devices; examples range from a simple tongue depressor to a life-sustaining heart valve. The regulation of medical devices can affect their cost, quality, and availability in the health care system.

In order to be legally marketed in the United States, many medical devices must be reviewed by the Food and Drug Administration (FDA), the agency responsible for protecting the public health by overseeing medical products, including devices. FDA’s Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device review. CDRH activities are funded through a combination of public money (i.e., direct FDA appropriations from Congress) and private money (i.e., user fees collected from device manufacturers) which together comprise FDA’s total. User fees account for 33% of FDA’s total FY2011 program level and 15% of CDRH’s program level, which is $378 million in FY2011 including $56 million in user fees. FDA’s authority to collect user fees, originally authorized in 2002 (
P.L. 107-250), has been reauthorized in five-year increments. It will expire on October 1, 2012, under the terms of the Medical Device User Fee Act of 2007 (MDUFA), Title II of the FDA Amendments Act of 2007 (FDAAA, P.L. 110-85).

FDA requires all medical product manufacturers to register their facilities, list their devices with FDA, and follow general controls requirements. FDA classifies devices according to the risk they pose to consumers. Premarket review is required for moderate- and high-risk devices. There are two paths that manufacturers can use to bring such devices to market. One path consists of conducting clinical studies, submitting a premarket approval (PMA) application and requires evidence providing reasonable assurance that the device is safe and effective. The other path involves submitting a 510(k) notification demonstrating that the device is substantially equivalent to a device already on the market (a predicate device) that does not require a PMA. The 510(k) process results in FDA clearance and tends to be much less expensive and less time-consuming than seeking FDA approval via PMA. Substantial equivalence is determined by comparing the performance characteristics of a new device with those of a predicate device; clinical data demonstrating safety and effectiveness are usually not required. Once approved or cleared for marketing, manufacturers must comply with regulations on manufacturing, labeling, surveillance, device tracking, and adverse event reporting.

Problems related to medical devices can have serious consequences for consumers. Defects in medical devices, such as artificial hips and pacemakers, have caused severe patient injuries and deaths. In 2006, FDA reported 116,086 device-related injuries, 96,485 malfunctions, and 2,830 deaths; an analysis by the National Research Center for Women & Families claims there were 4,556 device-related deaths in 2009. Reports published in 2009 through 2011—by the Government Accountability Office (GAO), the Department of Health and Human Services Office of the Inspector General and the Institute of Medicine—have voiced concerns about FDA’s device review process. In 2009 and 2011 GAO included FDA’s oversight of medical products on the GAO list of high-risk areas. FDA has conducted internal reviews as well and is implementing changes.

Date of Report: December 2
8, 2011
Number of Pages:
Order Number: R4213
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