ACLA Opposes US FDA’s Decision to No Longer Review EUA Requests for COVID-19 Lab Developed Tests

The FDA’s decision follows an announcement in August by the US Department of Health and Human Services that LDTs would not be required to undergo premarket review. The FDA has updated its Frequently Asked Questions on the development and performance of diagnostics for SARS-CoV-2, which includes the agency’s plan to decline to review EUA requests for LDTs. However, the FDA will continue to prioritize review of EUA requests for point-of-care tests, home collection tests, at-home tests and any tests that reduce dependence on testing supplies, as well as high-throughput, widely distributed tests. With this shift, the FDA aims to increase testing accessibility and capacity, according to the agency’s updated FAQs.

“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 FDA wrote. “We prioritize review of EUA requests for tests taking into account a variety of factors, including those discussed in the Emergency Use Authorization of Medical Products and Related Authorities Guidance, such as the public health need for the product and the availability of the product.”

However, the American Clinical Laboratory Association (ACLA Washington, DC, USA) has opposed the FDA’s decision to no longer review EUAs for lab-developed COVID-19 testing. A statement released by the ACLA President Julie Khani said, “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. Today’s announcement by the FDA creates unnecessary confusion.”

Related Links:
US Food and Drug Administration (FDA)
American Clinical Laboratory Association (ACLA)