The US FDA published plans to transition its COVID-19 guidance once the PHE ends.

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.

Learn more about FDA medical device regulations from Emergo by UL:

Comprehensive Guide to FDA Clearance for Your Medical and IVD Device

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US FDA Transitions COVID-19 Guidance Documents for the End of Public Health Emergency

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