The Trump administration implemented a policy that limited the US Food and Drug Administration’s review process of certain laboratory tests, including some COVID-19 tests. The Biden administration is now withdrawing the policy as announced by the US Department of Health and Human Services on Monday.

Last year, the Trump administration decided that premarket approval of laboratory-developed tests, or LDTs, would no longer be required by the FDA. Prior to that decision, laboratories had to apply for permission to create and use their own COVID-19 tests. However, the decision to limit this process meant that manufacturers of those tests developed by certain labs, such as Quest Diagnostics, LabCorp, or those at academic medical centres, could distribute their tests without first submitting documentation for FDA review.

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“The policy directed FDA not to require premarket review for LDTs, including premarket approval (PMA) or clearance (510(k)), and emergency use authorization (EUA), even in situations where they have poor performance. By withdrawing the policy, HHS is helping to ensure that COVID-19 tests work as intended. Effective today, HHS no longer has a policy on LDTs that is separate from FDA’s longstanding approach in this area,” HHS Secretary Xavier Becerra said in a statement Monday.

COVID-19 testing, according to Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, remains a “cornerstone” of the nation’s response to the ongoing pandemic. 

The agency stated that its actions were intended to increase access to COVID-19 tests that were “accurate and reliable”.

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“The FDA remains committed to helping to increase the availability of tests that will have the biggest impact on the nation’s ongoing COVID-19 testing needs, such as at-home and point-of-care diagnostic tests that can be produced in high volumes,” Shuren said in part. “By focusing our review on these types of tests, and helping to ensure that available tests have appropriate oversight, we can better respond to the pandemic as the nation’s testing needs continue to evolve.”

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When the previous policy, directing the FDA not to enforce premarket review requirements for lab-developed tests, was announced last year, some health experts commended the move, while others expressed concern about the impact on the accuracy of COVID-19 testing.