# FDA Decisions for Investigational Device Exemption Clinical Investigations:  Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/fda-decisions-for-investigational-device-exemption-clinical-investigations-guidance-for-sponsors-clinical-investigators-institutional-review-boards-and-food-and-drug-administration-staff/187acde3-b11f-43f1-878d-aabbc39c393a

> FDA guidance document: FDA Decisions for Investigational Device Exemption Clinical Investigations:  Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff. Issue date: August 19, 2014. Get complete insights and analysis.

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## Details

- Title: FDA Decisions for Investigational Device Exemption Clinical Investigations:  Guidance for Sponsors, Clinical Investigators, 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: 2014-08-19
- Last Changed: 2021-04-26
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0790">FDA-2011-D-0790</a>

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