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Volume 348:191-192 January 16, 2003 Number 3 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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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 . . . [Full Text of this Article]

Source Information

From the Center for Devices and Radiological Health (D.W.F., S.N.D.), and the Office of the Commissioner (M.M.), Food and Drug Administration, Rockville, Md.

Related Letters:

Outbreaks of Infection Associated with Bronchoscopes
Cetre J.-C., Salord H., Vanhems P., Srinivasan A., Perl T. M., Schaffner W., Jones T. F.
Extract | Full Text | PDF  
N Engl J Med 2003; 348:2039-2040, May 15, 2003. Correspondence

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