Ensuring Safe and Effective Medical Devices

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Abstract
Over 8000 new medical devices are marketed in the United States each year. Before marketing, manufacturers of high-risk, or class III, devices provide the Food and Drug Administration (FDA) with scientific clinical evidence that the devices are “safe and effective”; 50 to 80 of these devices receive FDA approval annually. Some 3500 medium-risk (class II) products are approved for marketing by the FDA after the manufacturer has submitted a 510(k) notification. The device must be “substantially equivalent” to an existing marketed device, as demonstrated by product-specific performance requirements or “special controls.” Only 8 percent of 510(k) notifications have special controls . . .

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