FDA Opens Path for States to Regulate COVID-19 Tests

Regulatory NewsRegulatory News | 17 March 2020 |  By 

As part of efforts to speed the development of certain laboratory tests for COVID-19, the US Food and Drug Administration (FDA) late Monday updated guidance to enable states to oversee certain tests.

“States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA,” FDA Commissioner Stephen Hahn said in a statement.  

The shift comes as difficulties with the Emergency Use Authorization (EUA) process has held back some tests. Keith Jerome, director of the University of Washington Virology Lab, told the New Yorker that his lab had to call and e-mail FDA multiple times to figure out what they needed to secure an EUA. “At one point, he was very frustrated because he’d e-mailed them what we were doing so they could review it,” Jerome said. “But legally you also had to mail a physical copy.”

The American Society of Microbiology sent a letter to FDA in late February, expressing concerns about the effects that the EUA process were having on the use of diagnostic tests by clinical laboratories amid the COVID-19 outbreak. A day later, FDA issued this immediately-in-effect guidance to allow some labs to use their tests before an EUA.

Now, in the updated guidance, the agency said that commercial manufacturers can develop tests for coronavirus and begin using them, once validated, for 15 business days ahead of an EUA request, and where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on its website.

And FDA issued two more EUAs late Monday for Hologic for its Panther Fusion SARS-COV-2 Assay, and LabCorp for its COVID-19 RT-PCR test. Two other EUAs were also granted to Roche and Thermo Fisher Scientific over the weekend.

But the agency pushed away from the use of EUAs with a new policy that allows for serological testing without an EUA. According to FDA, serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to an infection. 

“FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests, for example, noting the test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status,” the agency said.

Meanwhile, the policy for putting together an EUA remains unchanged from the initial publication of the guidance in February.

Sen. Elizabeth Warren (D-MA) also sent a letter on Tuesday to Vice President Mike Pence in his capacity as head of the White House Coronavirus Task Force, seeking answers on the administration’s "continued failure to ensure a sufficient number of diagnostic testing kits for COVID-19 are available, and its inability to provide clear and honest answers about this problem in the midst of this public health emergency, is unacceptable."

Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency


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