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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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2016-D-1159
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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

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