Report

Guidance for Industry & FDA Staff In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency

This document provides guidance on the type of information and data that FDA (Food and Drug Administration) recommends healthcare providers include in an Emergency Use Authorization (EUA) request for in vitro diagnostic (IVD) devices intended for use in diagnosing 2009 H1N1 Influenza virus infections during the emergency involving Swine Influenza A as declared by the Secretary of the Department of Health and Human Services (HHS). http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM188679.pdf

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Report

Guidance for Industry & FDA Staff In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency

This document provides guidance on the type of information and data that FDA (Food and Drug Administration) recommends healthcare providers include in an Emergency Use Authorization (EUA) request for in vitro diagnostic (IVD) devices intended for use in diagnosing 2009 H1N1 Influenza virus infections during the emergency involving Swine Influenza A as declared by the Secretary of the Department of Health and Human Services (HHS). http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM188679.pdf

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