SILVER SPRING, Md., Oct. 17, 2011 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration has issued a proposed rule and draft special controls guidance lowering the risk classification for external pacemaker pulse generators from Class III (high-risk) to Class II (moderate-risk)….
http://www.prnewswire.com/news-releases/fda-proposes-lower-risk-classification-special-controls-for-external-pacemakers-131990853.html
