The U.S. FDA will no longer review lab-developed tests (LDTs) for the SARS-CoV-2 virus under the emergency use authorization (EUA) program, a change that will eliminate any prospect of immunity from liability for these tests. The FDA’s Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, announced the news on the weekly COVID-19 testing town hall, but the change was simultaneously unveiled in the FDA’s Q&A for testing.
The Department of Health and Human Services issued a rescission order in August, declaring that the FDA was not statutorily authorized to require developers of LDTs to go through the EUA program prior to practicing the test. The HHS move was not limited to the pandemic, however, and was backed by the argument that any such regulation mandated the use of the notice-and-comment process employed during rulemaking. A major drawback to that policy is that any products invoking the EUA process under the terms of the public health emergency enjoy immunity from product liability thanks to the Public Readiness and Emergency Preparedness Act. Conversely, any pandemic-related product that goes to market without an EUA enjoys no such protection.
Stenzel prefaced the news with the advisory that this was “an important announcement,” and proceeded to recite the updated text of the FAQ. The update noted that the agency has prioritized several considerations, such as overall testing volume, tests that require little of supplies that may be short and site-of-testing technologies. “In light of this and the recent HHS announcement that FDA will not require premarket review of LDTs … FDA is declining to review EUA requests for LDTs at this time,” the update said.
Stenzel said the change will allow the agency to continue to emphasize testing capacity, but this updated policy did not find universal favor. Julie Khani, president of the American Clinical Laboratory Association (ACLA), said in an Oct. 7 statement, “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.” Khani said that such tests “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,” she said, adding that the latest policy change “creates unnecessary confusion.”
The Advanced Medical Technology Association told BioWorld that its standing policy on regulation of LDTs is unchanged from the time of the August rescission order. Advamed’s president and CEO, Scott Whitaker, said at the time that the Trump administration should take steps to ensure that developers of LDTs and in vitro diagnostics are subject to the same standard of test validation both during the pandemic and after.