FDA Reclassifies Certain Digital Mammography Devices

The U.S. Food and Drug Administration 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.

source: Medical News Today