Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post.

On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 Test Policy Guidance to encourage test developers to pursue full marketing authorization as opposed to Emergency Use Authorizations (EUAs). The agency will prioritize EUA reviews for:

• Diagnostic tests that are likely to have significant benefits for public health (such as those that employ new technologies);
• Diagnostic tests that are likely to fulfill an unmet need (such as diagnosing infection with a new variant or subvariant); 
• Supplemental EUA requests for previously authorized tests when the request is intended to fulfill a condition of authorization or includes a modification that will significantly benefit public health or fulfill an unmet need; and 
• Tests for EUA requests from (or supported by) a U.S. government stakeholder, such as tests funded by the Biomedical Advanced Research and Development Authority or the National Institutes of Health’s Rapid Acceleration of Diagnostics. 

Note: There has been no movement on the draft Transition guidance since comments closed in March 2022; however, our FDA + Healthcare Regulatory and Compliance team will continue to monitor  and report on any developments. 

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