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.
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.