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FDA Exempts Viral Transport Media from Some Requirements During Pandemic

November 16, 2021

While the public health emergency caused by the COVID-19 pandemic continues, the FDA does not intend to object to the distribution and use of viral transport media devices by commercial manufacturers without submission of a premarket notification, the agency said in a revised guidance released Monday.

The FDA also does not intend to enforce the Unique Device Identification or Quality System requirements for these media, but it will enforce labeling requirements.

It is important that viral transport media “are appropriately designed and validated prior to distribution to ensure that the transport medium will preserve the viral particles without meaningful degradation that could lead to inaccurate test results,” the agency said.  

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