FDAnews Device Daily Bulletin

HEART DEVICE MAKERS PLAN ENHANCED SAFETY REVIEWS

May 17, 2006
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Two major producers of heart devices, responding to a report by a medical group critical of industry's oversight of product safety, said yesterday that they planned to broaden how they conducted such reviews. In separate statements, the two companies, Medtronic Inc. and St. Jude Medical, said they planned several steps to heighten their scrutiny of device safety and reliability, like increasing the number of outside doctors who serve as consultants reviewing such issues. The New York Times (http://www.nytimes.com/2006/05/16/business/16device.html?_r=1&adxnnl=1&oref=slogin&adxnnlx=1147788131-y93tKA8u256SpZqc9r5bKA)