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USFDA Guidance: Traditional Pre-Market Pathways for COVID Tests

Yesterday (27-September, 2022) USFDA released revised guidance on "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency " to provide FDA’s review priorities and enforcement policies regarding novel coronavirus (COVID-19) tests for the duration of the public health emergency.

The announcement of the guidance is published in the Federal Register on September 28, 2022.


This guidance applies to diagnostic and serology tests for COVID-19. FDA is issuing this guidance to provide FDA’s review priorities and enforcement policies regarding novel coronavirus (COVID-19) tests for the duration of the public health emergency.


This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. FDA continues to assess the evolving situation and intends to update this guidance as appropriate.


The updated policy describes the FDA’s intent to review only a small subset of new emergency use authorization (EUA) requests for diagnostic tests and encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways.


Click this LINK to know more about this guidance and click this LINK to know about the shift from EUAs to traditional premarket pathways o stated by Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

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