HHS Revokes Trump Administration Policy Limiting FDA Review of Certain Covid-19 Tests – Community News
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HHS Revokes Trump Administration Policy Limiting FDA Review of Certain Covid-19 Tests

Trump administration says FDA no longer requires premarket review of certain lab tests, including some Covid-19 tests

Last year, the Trump administration ruled that the FDA would no longer require a pre-market review of lab-developed tests, known as LDTs. Prior to that determination, labs had to submit applications to develop and use their own Covid-19 tests. But the move to restrict that process meant that makers of Covid-19 tests developed by certain labs — such as Quest Diagnostics, LabCorp, or those in academic medical centers — could distribute their tests without first submitting documentation to the agency for review. FDA before they were put on the market.

“The policy has instructed the FDA not to require a premarket assessment for LDTs, including premarket approval (PMA) or approval (510(k)), and emergency authorization (EUA), even in situations where they perform poorly. “Revoking the policy, HHS helps ensure that COVID-19 testing works as intended. As of today, HHS no longer has a policy on LDTs ​​that is separate from the FDA’s long-standing approach to this matter,” HHS Secretary Xavier Becerra said in a statement Monday.
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dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a separate statement Monday that Covid-19 testing remains a “cornerstone” of the country’s response to the ongoing pandemic.

The agency said its actions were aimed at increasing access to “accurate and reliable” Covid-19 testing.

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

When the previous policy was announced last year ordering the FDA not to enforce pre-market assessment requirements for lab-developed tests, some health experts welcomed the move, while others were concerned about what it could mean for Covid-19 accuracy. tests.

“The main issue is whether the FDA has the capacity to move applications in an absolutely larger number of applications quickly through the process,” said Mara Aspinall, a professor of practice in the College of Health Solutions at Arizona State University. “It will be interesting to watch.”