(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. 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. A change in guidancePrior to this announcement, laboratories submitted emergency use authorization applications to develop and use their own Covid-19 tests. "These labs are normally allowed to produce and use lab developed tests (i.e.

Source: CNN August 21, 2020 18:33 UTC