On September 27, the Food and Drug Administration (FDA) updated its Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) Guidance for Developers and Food and Drug Administration Staff to provide priorities and enforcement policies regarding novel coronavirus (COVID-19) tests for the duration of the public health emergency. The updates supersede the previous policy released on November 21, 2021. Recently, CAP leaders met with FDA officials to discuss issues pathologists have encountered with the emergency use authorization (EUA) process during the COVID-19 pandemic.

The guidance pertains to clinical laboratories (ie, high-complexity CLIA-certified laboratory) that modify an authorized COVID-19 molecular diagnostic test, including:

• Those EUA authorized a different entity developed tests; and
• The modifications do not change the indication for use (eg, including new/different extraction kits or instruments that would not be expected to change the indication for use); and do not change the analyte-specific reagents (eg, the modifications do not change the PCR primers and/or probes).

From the guidance, the FDA intends to focus its review of EUA requests for tests that likely have a significant public health benefit (eg, employ innovative technology) or fulfill an unmet need (eg, diagnosing infection with a new variant or subvariant). In addition, the FDA also intends to focus its review on EUA requests from or supported by tests funded by the Biomedical Advanced Research and Development Authority (BARDA) or the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx).

Test developers will be notified by email if the FDA declines to review or decides not to authorize a test/modification in an EUA request.

The FDA will not require notification or submission of a new EUA if the modifications are validated and confirmed to show equivalent performance to the original EUA and if the use of the test is limited to the clinical laboratory in which made the modification. However, for other modifications, including new specimen types, test settings (eg, point-of-care, home testing), and new patient populations (eg, asymptomatic individuals) the FDA expects clinical laboratories to submit an EUA or traditional premarket review submission.

States listed on the FDA’s website can authorize tests developed by clinical laboratories within that state for use within that laboratory. This does not include at-home tests, tests with home specimen collection, or any testing outside a high-complexity, CLIA-certified laboratory.