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FDA Should Require More Labeling of Emergency Zika Diagnostics: GAO

May 31, 2017

The FDA should require manufacturers to include more labeling information on unapproved diagnostic devices authorized for use against the Zika virus, according to the Government Accountability Office.

In February 2016, HHS declared that the Zika virus posed a significant potential for a public health emergency and said the situation justified an Emergency Use Authorization (EUA) for Zika virus diagnostic tests.

Since then, the FDA has authorized two different types of diagnostic tests for Zika —molecular tests to detect genetic material in samples of bodily fluids and serologic tests to detect bloodstream antibodies against the virus.

The FDA has authorized several diagnostic tests under the program, but some performance characteristics were not consistently reported across different tests, making it more challenging to compare them, the GAO found.

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