The FDA has decided to streamline the path to market for digital mammography systems by reclassifying the systems from the Class III, or highest risk, to the Class II, or medium risk, category.
“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, MD, director of the FDA’s Center for Devices and Radiological Health.
When first approved by FDA in 2000, digital mammography systems were categorized as Class III. In the last decade, multiple scientific studies have validated digital mammography and the benefits and risks of digital versus film mammography have been well-described to physicians. Consequently, the FDA decided to reclassify digital mammography systems as Class II.
Along with the digital mammography reclassification, the FDA is releasing a “special controls” guidance for vendors 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.
The Class III device category typically includes new technology that has not been widely used and requires proof of safety and effectiveness before the product can be approved for marketing. Class II devices require submission of a premarket notification, or a 510(k), to establish that the product is substantially equivalent to a device already on the market.