# Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions:  Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/factors-to-consider-when-making-benefit-risk-determinations-for-medical-device-investigational-device-exemptions-guidance-for-investigational-device-exemption-sponsors-sponsor-investigators-and-food-and-drug-administration-staff/2b27b206-5d0c-408c-a6c2-d8e855da1e12

> FDA guidance document: Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions:  Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff. Issue date: January 13, 2017. Get complete insights and analysis.

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## Details

- Title: Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions:  Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators 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: 2017-01-13
- Comment Close Date: 2015-09-16
- Last Changed: 2020-10-20
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2015-D-1777">FDA-2015-D-1777</a>

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