# 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 - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/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/a1c94b70-4f6c-4666-86e7-be6a464f5281

> FDA 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. Issue date: December 05, 2017. Get complete insights and analysis.

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## Details

- Title: 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
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2017-12-05
- Last Changed: 2020-10-20
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2016-D-1159">FDA-2016-D-1159</a>

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