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FDA revises COVID test approach after HHS reverses Trump-era LDT directive

Posted 15 November 2021 | By Michael Mezher 

FDA revises COVID test approach after HHS reverses Trump-era LDT directive

The US Food and Drug Administration (FDA) on Monday revised its guidance on COVID-19 tests during the public health emergency after the Department of Health and Human Services (HHS) withdrew a Trump-era policy that restricted FDA from requiring premarket review for laboratory developed tests (LDTs).
Under the updated policy, FDA said it generally expects that newly offered COVID-19 tests will have an emergency use authorization (EUA) or traditional marketing authorization, and that it will be focusing its EUA review efforts on specific types of tests. Such tests include at-home and point-of-care diagnostics, high-volume antibody tests, and high-volume lab-based molecular diagnostics. FDA said it will also focus its resources on EUAs requested by, or supported by, government stakeholders, such as the Biomedical Advanced Research and Development Authority.
The agency also issued an umbrella EUA for serial testing with specific molecular diagnostic LDTs developed an performed by labs certified to perform high complexity tests.
"In addition to vaccination efforts, testing remains a cornerstone of the national response to the pandemic and plays a central role in helping Americans get back to work, school and other important activities, particularly as the holiday season approaches. 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,” said Jeff Shuren, director of the Center for Devices and Radiological Health.
FDA has traditionally exercised enforcement discretion with regard to most LDTs, and the agency has asserted that the tests fall under its regulatory purview as in vitro diagnostics. In recent years, the agency has limited its oversight of LDTs to what it considers to be higher risk technologies and had included LDTs in its COVID-19 test policies, allowing certain clinical laboratories to use tests it had validated prior to EUA submission.
However, in August 2020, under former HHS Secretary Alex Azar, HHS posted a brief memo to its website rescinding FDA’s guidances, compliance manuals and other informal issuances related to the premarket review of LDTs.
While HHS said that LDT developers could still voluntarily seek an EUA, FDA announced shortly after the policy was enacted that it would no longer accept EUA requests for COVID-related LDTs. (RELATED: FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs, Regulatory Focus 8 October 2020).
Now, HHS Secretary Xavier Becerra is walking back his predecessor's policy, giving FDA back the leeway it once had over LDTs.
"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," Becerra said.
FDA also announced that it will end its policy to allow some tests to be placed on the market after the test was validated and notification was provided to the agency. "Those policies were intended to expedite the availability of tests, though led to some poorly performing tests being offered prior to FDA review … With that in mind, and given the number of authorized tests available, the FDA is ending those notification policies going forward," FDA said.


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