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GUIDANCE DOCUMENT

FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff December 2017

Final
Docket Number:
FDA-2016-D-1159
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance modifies the Food and Drug Administration’s (FDA’s or the Agency’s) current policy on categorizing investigational device exemption (IDE) devices, which assists the Centers for Medicare & Medicaid Services (CMS) in determining whether or not an IDE device should be covered (reimbursed) by CMS.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-1159.