FDA Updates IDE Guidance Addressing Medicare Coverage
CMS may have an easier time determining when it should pay for an investigational device as FDA revamps its IDE device-classification scheme.
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The agency has long been partnering with CMS to set coverage for investigational device exemption studies by designating IDE trials as "category A" or "category B." A new FDA draft guidance and memorandum of understanding between FDA and CMS are intended to modernize the criteria for those trial categories.
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