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For Immediate Release: November 4, 2010
Media Inquiries: Dick Thompson, 301-796-7566, dick.thompson@fda.hhs.gov  
Consumer Inquiries: 888-INFO-FDA
FDA reclassifies certain digital mammography devices
Devices capturing digital image of breasts to be Class II
The U.S. Food and Drug Administration today announced that it is easing the pathway to market for mammography systems that produce computerized X-ray images of the entire breast.
These systems, known as Full Field Digital Mammography Systems, are an alternative to mammography systems that produce X-ray film.
When first approved by FDA in 2000, digital mammography systems were categorized as a high risk or Class III device, because they were then considered novel systems for screening and diagnosing breast cancer.
Since then, digital mammography has been well-validated in scientific studies involving tens of thousands of patients. The benefits and risks of digital versus film mammography have also been well -described to physicians. As a result, the FDA has decided to reclassify digital mammography from Class III devices to Class II or medium risk devices.
“Our decision to reclassify these devices is consistent with feedback we’ve received from public discussions with appropriate medical and scientific experts as well as our stronger understanding of how these systems work,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk among devices and include such products as heart valves and orthopedic implants. Companies must typically submit a premarket approval application for a Class III device, which requires proof of safety and effectiveness before the product can be approved for marketing. Many Class III devices involve 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.
For more information:
Federal Register Notice

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