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The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD) tests, not just COVID-19 tests. 

FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests

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The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD) tests, not just COVID-19 tests. During the height of the pandemic and while inundated with COVID-related submissions, CDRH restricted the IVD tests it would review in order to best address the public health crisis. Starting June 1, 2022, CDRH is again accepting all IVD pre-submissions, both COVID-related and other. However, the Center did include the caveat that non-COVID pre-submissions will likely still face an extended timeline, given the ongoing pandemic and associated workload.Read the <a href="https://lifesciences.mofo.com/topics/fda-will-once-again-accept-pre-submissions-for-all-in-vitro-diagnostic-tests.html">full blog post</a>.

FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests