FDA Revises Its Policy on Multi-Analyte COVID-19 EUAs

The FDA has updated its policy on COVID-19 testing, clarifying that manufacturers of multi-analyte respiratory panels which include SARS-CoV-2 are now eligible for Emergency Use Authorization (EUA).

The agency noted that multi-analyte panels are useful when multiple respiratory pathogens are circulating at the same time, as is expected with the upcoming flu season.

When determining whether to issue an EUA for a multi-analyte respiratory panel that includes SARS-CoV-2, the agency said it considers the clearance or approval status of diagnostics for the other analytes on the panel.