FDA Issues Final Guidance on Investigational Device Exemption Categorization

December 19, 2017 — 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.

On Dec. 2, 2015, the FDA’s Center for Devices and Radiological Health (CDRH) and CMS's Coverage and Analysis Group (CAG) executed a Memorandum of Understanding (MOU) to streamline and facilitate the categorization of investigational medical devices to support CMS’s ability to make Medicare coverage determinations for those devices. The Memorandum of Understanding (MOU) notes the need for the FDA and CMS to revise their shared understanding regarding categorization. The new guidance document will further implement the MOU by describing the process and information that will be used to help the FDA determine the appropriate category for an IDE and describe when the category assigned may be changed.

The FDA will discuss the final guidance at a webinar scheduled on Jan. 16, 2018 from 3:00-4:30 p.m. ET. The agency will respond to questions following a brief presentation.

For more information: www.fda.gov