FDA Won’t Require Premarket Approval for COVID-19 Lab-Developed Tests

In a dramatic policy reversal instigated by President Trump, the FDA will no longer require lab-developed tests (LDTs) for COVID-19 to undergo premarket review, the Department of Health and Human Services (HHS) announced Aug. 19.

The HHS notice says that LDT developers seeking approval, clearance, or an emergency use authorization for an LDT may still voluntarily submit a premarket approval application, premarket notification or EUA request, and the FDA will review such submissions.

Developers might still want to do so because otherwise, they would not be eligible for liability immunity under the Public Readiness and Emergency Preparedness Act.

HHS added that developers with an active Emergency Use Authorization (EUA) to use an LDT to detect COVID-19 or its antibodies are unaffected by the announcement.

The FDA’s handling of testing during the COVID-19 pandemic has come under criticism, and the HHS notice stresses that more flexibility is needed to address public health emergencies. The notice also referred to a need for rulemaking on the matter, suggesting the policy change could be longer lasting.

In reaction, Advanced Medical Technology Association President Scott Whitaker said the group “supports policies that foster innovation and regulatory flexibility to speed quality tests to patients,” but that it also encourages the administration “to ensure all diagnostic test developers, of both IVDs and LDTs, are subject to the same standard of test validation during the pandemic and beyond to protect patients and public health.”

The law firm Ropes & Gray noted “HHS’s announcement removes FDA’s ability to require that diagnostic test data be submitted in an EUA request and thus takes away FDA’s ability to prevent a test from being used and marketed if FDA has concerns with the data submitted.”