FDA Changes Digital Mammography Devices to Class II

The FDA has changed the classification of certain digital mammography devices from Class III to Class II with special controls. The change affects full-field digital mammography systems, which produce a digital image instead of X-ray film. When the FDA first classified the devices in 2000, they were considered novel systems for diagnosing breast cancer, which made them high-risk, the agency says. Since then, the FDA has come to a better understanding of how the devices work, CDRH Director Jeffrey Shuren says.