Trump admin says FDA will no longer require premarket review of certain lab tests, including Covid
Source: CNN
The Trump administration has determined that the US Food and Drug Administration will no longer review certain laboratory tests, including those used to detect Covid-19, according to an announcement from the US Department of Health and Human Services on Thursday.
The announcement -- which one expert said was part of a "bureaucratic fight" between HHS and FDA -- states that the FDA will not require premarket review of laboratory developed tests and this move is "part of HHS's ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19."
This means that makers of Covid-19 tests developed by certain individual laboratories -- such as Quest Diagnostics, LabCorp or those at academic medical centers -- can distribute them without the need to first submit documentation for a premarket review process. A laboratory developed test or LDT refers to a type of in vitro diagnostic test that is designed, manufactured and used within a single lab.
Prior to this announcement, laboratories submitted emergency use authorization applications to develop and use their own Covid-19 tests. The HHS announcement notes that labs seeking FDA clearance, approval or emergency use authorizations for their tests can continue to do so but are not required to.
Read more: https://www.cnn.com/2020/08/21/health/covid-lab-developed-tests-fda-hhs-bn/index.html
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Unbelievable (well, it is not, but UN--F>>kingBelievable) 
