FDA Reclassifications In Brief
This article was originally published in The Gray Sheet
Executive Summary
Digital mammography: FDA 1proposes May 30 to downclassify full field digital mammography systems from Class III to Class II, following the 2006 recommendation of its Radiological Devices Panel (2"The Gray Sheet" May 29, 2006, p. 6). The agency also released a special controls 3draft guidance outlining proposed electrical safety and physical laboratory 510(k) testing requirements. Comments on the proposed reclassification and draft guidance are due Aug. 29