On August 20, the Department of Health and Human Services announced that the FDA will no longer review certain laboratory tests, including some Covid-19 tests. The announcement states that the FDA will not require premarket review of laboratory developed tests as part of HHS's ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19.

Based on this new regulation, laboratories that develop tests can distribute them without needing to first submit documentation for a premarket review process. Laboratory developed tests (LDTs) are in vitro diagnostic tests that are designed, manufactured, and used within a single lab.

Previously, laboratories were required to submit emergency use authorization applications to develop and use their own. Laboratories may continue to seek this approval but are no longer required to do so. However, laboratories that use these tests without the approval would not be eligible for special benefits under the Public Readiness and Emergency Preparedness Act.

LTDs that have an active emergency use authorization for a laboratory developed test to detect the coronavirus causing Covid-19, or its antibodies, are unaffected by the new announcement. The new rule would eliminate several bureaucratic hurdles to laboratories in getting their tests to market quickly. However, without the regulatory approvals, the accuracy and standardization of any non-approved LDTs can come into question.

Source: Department of Health & Human Services, CNN, August 21, 2020