Neurovascular, Vascular Embolization Devices Shifting To Class II
This article was originally published in The Gray Sheet
Executive Summary
FDA is adding vascular devices to its proposed recategorization of neurovascular embolization devices from Class III to Class II with special controls
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Category A IDE coverage: CMS begins covering routine costs for clinical trials of Category A IDE devices, effective Jan. 1, implementing a provision in the Medicare Modernization Act of 2003, a Dec. 17 notice from the agency states. MMA stipulates that Category A devices - those for which "absolute risk" is not yet established - should be used to diagnose, monitor or treat immediately life-threatening conditions. In the Dec. 17 notice, the agency defines such conditions as "a stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment." In November, AdvaMed ExecVP-Healthcare Systems & Federal Legislative Policy Carol Kelly told "The Gray Sheet" that the trade association was seeking a precise definition of "life-threatening" that specified "some reasonable period of time"...
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