# Significant Risk and Nonsignificant Risk Medical Device Studies:  Guidance For IRBs, Clinical Investigators, and Sponsors - FDA Guidance Document

Source: https://www.keypedia.com/guidances/information-sheet/significant-risk-and-nonsignificant-risk-medical-device-studies-guidance-for-irbs-clinical-investigators-and-sponsors/bdf7fe5d-6ac5-437c-ada1-e0c1413282af

> FDA guidance document: Significant Risk and Nonsignificant Risk Medical Device Studies:  Guidance For IRBs, Clinical Investigators, and Sponsors. Issue date: January 01, 2006. Get complete insights and analysis.

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## Details

- Title: Significant Risk and Nonsignificant Risk Medical Device Studies:  Guidance For IRBs, Clinical Investigators, and Sponsors
- Communication Type: Information Sheet
- Product Type: devices
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2006-01-01
- Last Changed: 2023-08-10
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2006-D-0031">FDA-2006-D-0031</a>

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