Business · 05/12/2017

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

The Food and Drug Administration (FDA) has released a new guidance document to assist the Centers for Medicare and Medicaid Services (CMS) in making decisions on the coverage of investigational device exemption (IDE) devices, which are medical devices used in clinical trials. The guidance aims to streamline the categorization process, allowing CMS to more efficiently determine whether these devices should be covered by Medicare.