Use of COVID-19 Tests without FDA Approval Could Bring New, Innovative Tests to Market More Quickly

The US Department of Health and Human Services (HHS Washington, D.C., USA) has rescinded the guidance that mandated that COVID-19 tests secure approval from the Food and Drug Administration (FDA) before use, under an executive order from the US President Donald Trump.

The majority of COVID-19 tests currently used in the US are made by device manufacturers and hence, subject to FDA review. However, the latest decision will now allow private and commercial laboratories to manufacture and administer COVID-19 tests. Laboratory developed tests (LDTs) are generally not used in a pandemic setting, although the FDA had loosened restrictions on the tests to increase testing across the US due to the failed rollout of the Centers for Disease Control and Prevention’s (CDC's) test in February.


The FDA has strongly opposed the move by the Trump administration to block the agency from regulating a broad swath of laboratory tests, including for the coronavirus. Several health experts and laboratories have also expressed shock at the new policy due to its timing, several months into a pandemic. Public health experts have warned that unreliable coronavirus tests could flood the market due to the new policy, resulting in more people receiving erroneous results and worsening the testing crisis across the US. They believe that the shift in policy will hardly help in resolving current testing problems, which are being caused primarily by shortages of supplies such as swabs and chemical reagents. However, supporters of the new policy believe that the move is a positive one and would allow producers to quickly launch new and more innovative tests in the market by removing the bottlenecks created by the FDA review process.

The HHS has maintained that the policy shift was part of a review of the department’s COVID-19 response and consistent with administration efforts to reduce unnecessary regulation. In a document posted to its website, the HHS said "As part of HHS's ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19, the department has determined that the Food and Drug Administration will not require premarket review of laboratory developed tests absent notice-and-comment rule making."

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US Department of Health and Human Services (HHS)