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Home > Medical Professionals > Health Policy and Government Relations > Regulatory Issues > FDA Mandates TEVAR Tracking

FDA Mandates TEVAR Tracking

FDA requires manufacturers to track certain devices in order to facilitate notification and recall in the event that a device presents a serious risk to health that requires prompt attention. The Guidelines from August 15, 2008 have added thoracic aortic aneurysm stent grafts to the list of devices subject to medical device tracking requirements. The entire guidelines can be accessed here.