Posts tagged Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
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FDA Confirms That At-Home Collection Kits Are Not Authorized for Use with COVID-19 Tests
Categories: Coronavirus (COVID-19), FDA
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On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist laboratories and commercial manufacturers in development of diagnostic tests for the novel coronavirus (“COVID-19”) during the ongoing pandemic.

During the first week of implementation, questions arose regarding the extent to which the Emergency Use Authorization (“EUA”) pathway to market, as described by the Policy, covers at-home ...

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