# Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/consideration-of-uncertainty-in-making-benefit-risk-determinations-in-medical-device-premarket-approvals-de-novo-classifications-and-humanitarian-device-exemptions-guidance-for-industry-and-food-and-drug-administration-staff/fa2f7c02-f5db-49ed-a379-d25573c9b9f9

> FDA guidance document: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions:  Guidance for Industry and Food and Drug Administration Staff. Issue date: August 30, 2019. Get complete insights and analysis.

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## Details

- Title: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions:  Guidance for Industry 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: 2019-08-30
- Last Changed: 2019-08-29
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-3130">FDA-2018-D-3130</a>

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