FDA Reclassifies Certain Digital Mammography Devices
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.
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