HHS withdraws Trump administration policy restricting FDA review of some Covid-19 tests

Trump administration says FDA will no longer require pre-market review for certain lab tests, including some Covid-19 tests

Last year, the Trump administration determined that the FDA would no longer require pre-market review of lab-developed tests, known as LDTs. Prior to that decision, laboratories were required to submit applications to develop and use their own Covid-19 tests. But that move to limit the process means that manufacturers of Covid-19 tests are developed by certain labs – such as Quest Diagnostics, LabCorp or those at medical centers. academic institutions – can distribute their tests without having to submit documents first to be reviewed by the FDA before they are released on the market.

“Policy directs FDA to not require pre-market review for LDT, including pre-market approval (PMA) or clearance (510(k)) and emergency use authorization (EUA), even in situations where they perform poorly. 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 this. LDT is separate from the FDA’s longstanding approach in this area”, HHS Secretary Xavier Becerra said in a statement Second.
& # 39;  Trouble & # 39;  Laboratory association says tests to check for past coronavirus infections are flooding the US
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a separate statement on Monday that Covid-19 testing remains a “platform” in the nation’s response to the ongoing pandemic.

The agency said its actions were to aim and increase access to “accurate and reliable” Covid-19 tests.

“The FDA remains committed to helping to increase the availability of tests that will have the greatest impact on the nation’s ongoing COVID-19 testing needs, such as in-home and point-of-care diagnostic tests.” squirrels can be produced in large quantities,” said Shuren. “By focusing our assessment on these types of tests and helping to ensure that the tests are available with proper supervision, we can better respond to the pandemic as the nation’s testing needs continue to grow.”

When a previous policy announced last year directed the FDA not to enforce pre-market review requirements for lab-developed tests, some health experts welcomed the move in as others expressed concern about its implications for the accuracy of Covid-19 testing.

Mara Aspinall, professor of practice at the University of Health Solutions in Arizona State University. “It will be interesting to see.”


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