Business · 01/06/2016

FDA Publishes Draft Guidance on Categorization of Investigational Device Exemption Devices for Medicare Coverage Decisions

The Food and Drug Administration (FDA) has released a draft guidance document aimed at clarifying the framework for categorizing investigational device exemption devices to assist the Centers for Medicare and Medicaid Services (CMS) in making coverage decisions, following a Memorandum of Understanding (MOU) signed in 2015 between FDA and CMS.