FDA Reclassifies Predestined Digital Mammography Devices


The U.S. Food and Drug Administration appear that it is abatement the alleyway to bazaar for mammography systems that aftermath computerized X-ray images of the absolute breast.

These systems, accepted as Full Field Agenda Mammography Systems, are an another to mammography systems that aftermath X-ray film.

When aboriginal accustomed by FDA in 2000, agenda mammography systems were categorized as a aerial accident or Class III device, because they were again advised atypical systems for screening and diagnosing breast cancer.

Since then, agenda mammography has been well-validated in accurate studies involving tens of bags of patients. The allowances and risks of agenda against blur mammography accept additionally been able-bodied -described to physicians. As a result, the FDA has absitively to reclassify agenda mammography from Class III accessories to Class II or average accident devices.

“Our accommodation to reclassify these accessories is constant with acknowledgment we’ve accustomed from accessible discussions with adapted medical and accurate experts as able-bodied as our stronger compassionate of how these systems work,” said Jeffrey Shuren, M.D., administrator of the FDA’s Center for Accessories 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.