FDA issues rules for H1N1 diagnostic tests

Although there are no FDA-approved or cleared tests that diagnose the viral infection, during the current pandemic manufacturers can submit a request for an Emergency Use Authorization. If granted, the EUA will allow the test to be used. The new FDA document outlines what information the FDA recommends that manufacturers include in an EUA request.

The FDA said its guidance document is part of ongoing efforts to provide public health authorities managing the pandemic with reliable and accessible diagnostic tests.

The guidance is available online at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/....

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