"FDA will no longer review EUAs for COVID-19 LDTs"

"FDA will no longer review EUAs for COVID-19 LDTs"

Yes, the FDA stopped pre-market reviews of LDTs in August.

https://www.cdc.gov/csels/dls/locs/2020/fda_s...CoV-2.html

But the Innova tests are not LDTs.

Quote:

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A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.
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While the uses of an LDT are often the same as the uses of FDA-cleared or approved in vitro diagnostic tests, some labs may choose to offer their own test. For example, a hospital lab may run its own vitamin D assay, even though there is an FDA-cleared test for vitamin D currently on the market.

The FDA does not consider diagnostic devices to be LDTs if they are designed or manufactured completely, or partly, outside of the laboratory that offers and uses them.

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https://www.fda.gov/medical-devices/vitro-dia...oped-tests

The FDA has continued to issue EUAs for Molecular, Antigen and Serological Diagnostic Tests. Here is the FDA's updated In Vitro Diagnostics EUAs listing.

https://www.fda.gov/medical-devices/coronavir...stics-euas