COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Issues Amendment to Streamline Authorization Process for Pooled COVID-19 Testing

FDA maze of regulations

New FDA amendment allows existing EUAs for COVID-19 testing to be authorized quickly for pooled testing

The US Food and Drug Administration (FDA) has issued an amendment to the authorization process for pooled COVID-19 testing to streamline the process. The recent amendment allows test developers to have diagnostic tests more easily approved for pooled testing and be used for serial testing.

This new amendment allows diagnostic COVID-19 tests that have previously received an emergency use authorization (EUA) to be used to perform pooled testing for SARS-CoV-2 if the test developer self-certifies that they have validated the test for pooled testing.

This amendment only applies to tests that use anterior nasal respiratory specimens and that are being used at least once a week as part of a serial testing program. The amendment also does not change or waive any other requirements included in the EUAs being amended.

To amend previously issued EUAs to offer pooled testing using this amendment, test developers must notify the FDA and submit validation data along with the pooling procedures that will be used. The test will then be listed on the FDA’s website as allowed for pooled testing, and the test’s EUA will be amended to reflect the change.

Test developers or clinical laboratories wishing to view the amendment and its requirements in full can do so here.

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