SILVER SPRING, Md., Nov. 4, 2010 /PRNewswire-USNewswire/ — 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.
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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 i
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