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FDA Updates Its Criteria For Medicare Coverage Of Device Trials

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for investigational device exemption studies by designating IDE trials as "category A" or "category B." A new FDA draft guidance and memorandum of understanding between FDA and CMS are intended to modernize the criteria for those trial categories.

Under a new draft policy, FDA will have more flexibility to re-designate a device while it is being assessed in clinical trials so that future study of the product can qualify for expanded Medicare coverage.

The agency has played an important role in determining to what extent Medicare can cover device studies for more than...

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