Breast lesion mapping devices
This article was originally published in The Gray Sheet
Executive Summary
Documentation system software is "generally considered a 'minor level of concern,'" FDA notes in a July 28 1Class II special controls guidance outlining information on premarket submissions requirements. Nevertheless, "clear scientific justification that discusses the possible consequences of software failure" should be provided, the guidance states. The document accompanies a same-day final rule downclassifying the devices from Class III to Class II, spurred by a May 2002 petition regarding Assurance Medical's Breastview mapping system...