FDA Tightens the Screws on EUA Review of COVID-19 Tests

The public health emergency (PHE) might linger into 2023, but the FDA is already making the transition to the post-COVID-19 world. On Sept. 27, the agency posted a statement on its website announcing subtle but significant changes to its policy governing review of new lab tests for COVID-19.

The FDA’s EUA Policy

Of the more than 430 different COVID-19 tests that the FDA has cleared since the PHE began, all but a few have received Emergency Use Authorization (EUA). Resorting to the EUA pipeline enabling validated but not fully proven tests to reach the US market on an accelerated basis during a PHE made sense in the early days of the crisis when COVID-19 diagnostic products were in short supply. But the situation has changed. According to the agency’s statement, there’s now “sufficient testing capacity.” As a result, it says that “most future submissions are best suited for traditional premarket review pathways,” i.e., De Novo classification or 510(k) clearance.

While the situation is different, the policy is not. For nearly two years, the FDA has been calling on COVID test makers to use the traditional pathways for not only new products but also those that have already received EUA. On March 17, 2021, BioFire Diagnostics’ BioFire Respiratory Panel (RP) 2.1 became the first COVID-19 test to make the transition from EUA to De Novo clearance status. Last month, the FDA granted 510(k) clearance for the Simplexa COVID-19 Direct Kit, a swab-based PCR test from DiaSorin Molecular. 

The New FDA EUA Policy

Even so, COVID-19 test makers have been slow to take the FDA’s offer to pursue traditional premarket review for their products. So now, the agency is stepping up the pressure. The EUA pipeline will remain open, but new restrictions will apply. From now on the agency says 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).

“Taking into account the current status of manufacturing capacity and consumer access given the Administration’s important investments in tests, for most new tests, shifting to traditional premarket review would best meet the public health needs at the current stage of the COVID-19 public health emergency,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, about the FDA’s new policy, in the Sept. 27 statement.

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

Takeaway

We are entering a new era in COVID-19 lab testing and the way it’s regulated. Companies that have traveled the EUA pipeline to bring new COVID-19 tests to market now have to decide whether they’re in it for the long haul. As the EUA review process tightens, test makers that choose to remain in the COVID-19 market will have to start making the transition by seeking 510(k) or De Novo status for their products.

“Testing remains one of the key pillars in combatting the COVID-19 pandemic,” Shuren said in the FDA release. “The FDA will continue to offer support and expertise to assist with the development of accurate and reliable tests, and to facilitate continued access to tests for all Americans.”