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FDA draft guidance to assist CMS with coverage decisions for Medicare payment

On June 1, 2016, the US Food and Drug Administration (FDA) published in the Federal Register (81 Federal Register 35032) a draft guidance for sponsors, clinical investigators, industry, IRBs, and FDA staff regarding categorization of Investigational Device Exemption (IDE) devices as either a Category A or Category B device to assist the Centers for Medicare and … Continue reading