HHS withdraws Trump administration policy that limited FDA review of certain Covid-19 tests
CNN
The Biden administration is withdrawing a policy established under the Trump administration that limited the US Food and Drug Administration's review process of certain lab tests, including some Covid-19 tests. The US Department of Health and Human Services announced the withdrawal on Monday.
Last year, the Trump administration determined that the FDA would no longer require premarket review of laboratory-developed tests, known as LDTs. Prior to that determination, laboratories were required to submit applications to develop and use their own Covid-19 tests. But the move to limit that process meant that makers of Covid-19 tests developed by certain labs -- such as Quest Diagnostics, LabCorp or those at academic medical centers -- could distribute their tests without the need to first submit documentation for review by the FDA before they were marketed.
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