March 27, 2023
The FDA issued a notice identifying how the agency plans to transition the guidance documents related to COVID-19 once the public health emergency (PHE) ends. Notably, on medical devices, the guidance Policy for Coronavirus Disease-2019 Tests (Revised) and Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests are identified to remain in effect indefinitely. Most device-specific guidances will remain in effect 180 days after the PHE ends for transition.
Emergo by UL will post updates as they become available.
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