The FDA publishes rules for diagnostic tests H1N1
The Food and Drug Administration
indicates that it has developed guidelines issued by manufacturers to develop diagnostic tests for H1N1 influenza in 2009.
Although it is not FDA approved or authorized tests, to diagnose viral infection during the current pandemic of manufacturer in May to apply for authorization of emergency use. If granted, the USA will allow the test to use. The new FDA document describes what information the FDA recommends that manufacturers are located in the EEA.
The FDA said that its orientation is part of ongoing efforts in public health
Administrations of the pandemic, with diagnostic tests reliable and accessible.
The guide is available online at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM188679.pdf.
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