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# Guide on IDE Categorization for CMS Coverage Decisions
- URL: https://www.fdaweb.com/guide-on-ide-categorization-for-cms-coverage-decisions-2/
- Published: 2017-12-05T12:00:00.000Z
- Updated: 2026-09-14T23:05:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140271

*Federal Register* notice: FDA has made available a guidance entitled “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions.” The document modifies the agency’s current policy on IDE categorization, which assists CMS in determining whether or not an IDE device should be covered for reimbursement. It also explains the framework that FDA intends to follow for such categorization decisions. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-12-05/pdf/2017-26195.pdf?ref=fdaweb.com).