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# Draft Guide on IDEs Available for Medicare Coverage Decisions
- URL: https://www.fdaweb.com/draft-guide-on-ides-available-for-medicare-coverage-decisions/
- Published: 2016-06-01T12:00:00.000Z
- Updated: 2026-09-14T21:06:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135810

*Federal Register* Notice: FDA has published a draft guidance on “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions.” The document modifies FDA’s current policy on categorization of IDE devices, which assists CMS in determining whether an IDE device should be covered (reimbursed) by CMS. It also implements a 2015 Memorandum of Understanding between FDA and CMS that streamlines and facilitates the efficient categorization of investigational medical devices in order to support CMS’s ability to make Medicare coverage determinations. To view the guidance, click [here.](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm504091.pdf?ref=fdaweb.com) To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-06-01/pdf/2016-12828.pdf?ref=fdaweb.com).