The U.S. Food and Drug Administration (FDA) recently issued a final guidance, “FDA Categorization of Investigational Device Exemption Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions”, which modifies the FDA’s policy on categorization of IDE devices used in clinical studies. Devices with an approved Investigational Device Exemption (IDE) are categorized into one of two categories by the FDA — Experimental (Category A) devices or Nonexperimental/Investigational (Category B) devices — based on the level of risk the device poses to the patient. This categorization is used by CMS to determine whether an IDE device, and certain services related to those devices, may be covered by CMS.