The U.S. Food and Drug Administration (FDA) will no longer review emergency use authorization (EUA) requests for COVID-19 lab developed tests (LDTs). The agency outlined the change on its webpage FAQs on Testing for SARS-CoV-2, according to a press release.
“We are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized to be run in labs,” the agency wrote, adding that the “FDA is declining to review EUA requests for LDTs at this time.”
The FDA said it will prioritize reviewing EUA requests for other types of tests instead. “We have, for example, prioritized review of EUA requests for tests where authorization would increase testing accessibility (e.g., point of care [POC] tests, home collection tests, at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies, high-throughput, widely distributed tests),” the agency wrote.
The FDA’s decision not to review EUAs for LDTs follows an announcement in August from the Department of Health and Human Services (HHS) in which it said that labs would no longer be required to submit EUA requests for LDTs. At that time, HHS said labs that chose not to submit requests for EUA would not be covered under the Public Readiness and Emergency Preparedness Act (PREP Act), which allows the HHS secretary to issue a declaration providing immunity from liability for tests and other “medical countermeasures” against “chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics,” according to the HHS Office of the Assistant Secretary for Preparedness and Response.
It was not clear what impact, if any, the FDA’s decision not to review EUAs for COVID-19 LDTs would have on the applicability of the PREP Act.
Julie Khani, President of the American Clinical Laboratory Association (ACLA), released a statement opposing the FDA’s decision. “Many of the tests that have been granted EUAs for COVID-19 testing are innovative, high-throughput LDTs that have reduced reliance on supplies and been integral to expanding testing capacity. These are exactly the kinds of tests that FDA has stated it wants to prioritize. ACLA believes the FDA should continue to allow labs to voluntarily submit EUAs for FDA review and authorization. The announcement by the FDA creates unnecessary confusion,” Khani said.
