After more than 430 emergency green lights for COVID-19 tests since the start of the pandemic, the FDA is beginning to wind down its expedited reviews for coronavirus diagnostics, instead urging developers to follow its traditional regulatory paths to market.
The agency’s transition toward more normal, pre-crisis operations comes after President Joe Biden declared the COVID-19 pandemic over after more than two-and-a-half years. Since reaching a high point with almost 5 million per week during an omicron-fueled January surge, the number of positive cases has now evened out to about 500,000 per week, according to stats from Johns Hopkins University, as the virus moves into more endemic stages similar to diseases such as the flu.
The FDA said that going forward it plans to only review a small subset of applications for Emergency Use Authorizations and that all companies should consider seeking official de novo classifications or 510(k) clearances, which will allow their diagnostics to be sold after the U.S. government’s COVID-19 public health emergency declarations expire.
“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,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency release.
The tests that will be prioritized for emergency authorizations include diagnostics employing new technologies that are likely to have a significant benefit on public health, as well as those that tackle unmet needs such as newly spreading virus variants.
The agency will also accept tests funded by the Biomedical Advanced Research and Development Authority, or BARDA, and the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative, also known as RADx. In addition, any EUA requests that were previously pending will remain in the agency’s review queue.
“Testing remains one of the key pillars in combating the COVID-19 pandemic,” Shuren said. Under the agency's authorizations, U.S. manufacturers have the capacity to produce up to hundreds of millions of tests per month, although the exact number of tests available on store shelves will depend on public demand and other supply chain factors, according to the FDA.
The FDA granted its first full de novo clearance to a COVID-19 test in March 2021. The nod went to BioFire Diagnostics' screener that checks for multiple infections to help identify coronavirus cases among people with the flu, respiratory syncytial virus or the bugs behind the common cold. Since then, the agency said it has greenlit other tests of the same type using the 510(k) clearance process.