- The FDA is encouraging COVID-19 test manufacturers to seek authorization now through the traditional premarket review process to ensure their testing products will be permitted to be marketed beyond the U.S. public health emergency.
- Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, recommended that antigen test developers in particular pursue "conversions" of emergency use authorizations to fully authorized versions of their products. "A De Novo pathway is the process for the first successful submitter. All subsequent submitters will then be authorized under the 510(k) pathway," Stenzel said during a virtual town hall meeting on Wednesday. "Go ahead and get in line," the agency's testing chief told test makers, hastening to add that first in submissions don't necessarily mean first out depending on "whether any additional work may be needed."
- BioFire Diagnostics last year became the first company to secure a full FDA marketing authorization for a COVID-19 test. The molecular diagnostic, which previously had an EUA for the detection of 22 respiratory pathogens including SARS-CoV-2, was granted authorization using the FDA's De Novo premarket review pathway. As a result, Stenzel noted in Wednesday's town hall that all follow-on molecular tests for point-of-care laboratory use may go through the 510(k) process. FDA has not yet granted full marketing authorization for COVID-19 antigen or serology tests.
COVID-19 tests that have emergency use authorizations are only permitted for use during the U.S. public health crisis and the emergency use declarations that allowed FDA to issue EUAs. Test developers will need to get diagnostics authorized using traditional premarket review processes to support post-pandemic use.
The FDA is recommending manufacturers do so sooner rather than later.
Antigen tests from manufacturers such as Abbott Laboratories, Becton Dickinson and Quidel have all received FDA emergency use authorizations. In late March 2021, diagnostics from all three companies got EUAs for asymptomatic COVID-19 serial screening.
BD in October announced a partnership with the U.S. Biomedical Advanced Research and Development Authority to achieve full 510(k) clearance of BD's Veritor combination SARS-CoV-2, Influenza A and Influenza B test — as well as develop new combo tests on other platforms — to help ensure availability and access to diagnostics even after the COVID-19 public health emergency is declared to be over.
"For antigen tests, the recommendations for full authorization — whether it's a De Novo or a 510(k) — are essentially the same," Stenzel told test developers on Wednesday. However, with De Novo authorization, Stenzel emphasized that the FDA involves "more work" for the agency due to criteria called special controls that define the requirements related to labeling and performance testing.
Stenzel said the special controls, combined with general controls, provide a reasonable assurance of safety and effectiveness, creating a new regulatory classification so that subsequent tests of the same type with the same intended use may go through the FDA's 510(k) clearance by demonstrating substantial equivalence to a predicate device.
"The testing, the validation is essentially the same" for the first De Novo and the second and subsequent 510(k) authorizations, Stenzel said, adding that test makers who are planning to perform EUA studies now should consider continuing to do so to collect data for full authorizations in order to avoid having to restart later.
At this time, the FDA's testing chief said the agency is "encouraging all EUAs to go ahead and perform their conversion studies."
FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to terminate their authorizations, in anticipation of the public health emergency declarations no longer being in effect.
Cowen analysts earlier this week reiterated their opinion that the U.S. public health emergency "will likely be extended at least one more time, from April 15 until July 15."
However, Stenzel on Wednesday warned that the pattern the virus will take is difficult to predict as the BA.2 subvariant, which spreads faster than the earlier omicron variant, has more than doubled in the U.S. over the past two weeks, and data from the U.S. Centers for Disease Control and Prevention show the variant represents more than a third of COVID-19 cases that have undergone genetic sequencing.
"In all likelihood, we may see a slight resurgence in COVID in the coming weeks and months. The number of positives should increase if old patterns hold," according to Stenzel. "We're seeing resurgent omicron BA.2 in Europe and we're just anticipating because of past historical patterns that we'll see that here too."
Under existing EUAs for coronavirus tests and once they are fully authorized through the De Novo or 510(k) pathways, the FDA expects test developers to continue to routinely monitor and evaluate the performance impact of SARS-CoV-2 viral mutations on their diagnostics for as long as they are being offered.