Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Intuitive Surgical responds to FDA investigation of increased adverse event reports. Groups call on FDA to change its Freedom of Information Act policy. More regulatory news.
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Regulatory News In Brief
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Caution on robotic surgery from Ob/Gyn group. FDA gets closer to gaining access to most of fiscal 2013 user fees. More news.
FDA Investigates Adverse Events Reported With Da Vinci Robot
An apparent increase in adverse event reports with Intuitive Surgical’s popular robotic surgery system has triggered further inquiry from FDA.