The FDA’s policy on Emergency Use Authorization (EUA) for COVID-19 tests remains a work in progress. On Sept. 27, the agency posted a statement on its website declaring that current testing capacity is adequate and establishing limits on its review of new EUA submissions. Here’s a quick briefing of the new FDA policy.

The New Policy

More than 430 different COVID-19 tests have reached the US market via the EUA pipeline since the public health emergency began. Having achieved “sufficient testing capacity,” the agency expressed its belief that “most future submissions are best suited for traditional premarket review pathways,” i.e., De Novo classification or 510(k) clearance.

Accordingly, the agency says that from now on, it will “focus its review” on COVID-19-related EUA requests (and supplemental requests) from “experienced developers” for:

• Tests likely to have a significant public health benefit, such as tests using new technologies;
• Tests likely to fulfill an unmet need, such as tests diagnosing infection with new variants or subvariants;
• Supplemental EUA requests for previously authorized tests that are intended to fulfill a condition of authorization or include a modification that will significantly benefit public health or fulfill an unmet need; and
• Tests requested or supported by a federal government stakeholder, such as tests funded by the Biomedical Advanced Research and Development Authority (BARDA) or the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx).

EUA requests for COVID-19 tests that were in the pipeline before the new policy announcement “will remain in the queue,” the agency added.

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Here are some of the key new FDA EUAs and clearances that were announced in September 2022:

New FDA Emergency Use Authorizations (EUAs) & Approvals

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New CE Markings in Europe

Other international clearances announced during the period: