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FDA Reclassifies Certain Digital Mammography Devices
Date:11/4/2010

nvolve new technology that has not been widely used.

Class I and Class II devices pose lower risk and include adhesive bandages, wheelchairs, and many medical imaging technologies, such as MRI scanners and screen-film X-ray mammography. Class II devices require submission of a premarket notification, also known as a 510(k), to establish that the product is substantially equivalent to a device already on the market.

Along with the digital mammography reclassification, the FDA is releasing a "special controls" guidance for industry that describes what evidence will be needed to show substantial equivalence for these systems, including technical device specifications, images of standard test objects, and a sample set of patient images.

The FDA has approved five full field digital mammography systems since 2000, all were approved as Class III devices. About 70 percent of the mammography units in use are digital and 70 percent of certified U.S. mammography facilities have at least one digital unit, according to FDA reports from certified mammography facilities.

In May 2006, the FDA publicly discussed plans to reclassify FFD mammography systems from Class III to Class II at a Radiology Devices Panel meeting. After the positive response from the panel, the FDA published draft guidance for public comment in May 2008. The panel held another public meeting in November 2009 to discuss the comments received on the draft guidance.

Other than skin cancer, breast cancer is the most common type of cancer among women in the United States. An estimated 207,100 new cases of breast cancer in women will be diagnosed in 2010, according to the National Cancer Institute.

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Federal Register Notice


SOURCE U.S. Food and Drug Administration
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