The Food & Drug Administration made it easier for developers of full-field digital mammography systems to get the devices approved for the U.S. market.
The federal watchdog agency reclassified the Class III devices as Class II, or medium-risk, because of adequate clinical data verifying the breast scanners’ safety.
"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,"the FDA’s Center for Devices and Radiological Health director Jeffery Shuren said in prepared remarks.
The agency cited scientific studies involving tens of thousands of patients which have been conducted with the devices since 2000. The devices had been classified as high-risk, or Class III, because of the lack of clinical data attesting to their safety.
The new classification means digital mammography developers will use the 510(k) application for new systems they’re looking to launch. The 510(k) program enables companies to rely the safety record of devices using the same technology, so-called predicate devices, to prove their overall safety. They are no longer considered novel technology for screening and diagnosing breast cancer, according to the FDA.
Thus far, the agency has approved five digital mammography systems. It has been discussing plans to ease the devices’ regulatory pathway since May 2006. Guidance for companies seeking to market new FFDM devices is available on the FDA’s website.
