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
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Investigational Device Exemption (IDE)
Published
December 5, 2017
Last updated
October 20, 2020
Description
FDA provides guidance on categorizing Investigational Device Exemption (IDE) devices to assist CMS with coverage decisions.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)