Feds OK use of COVID-19 tests without FDA approval

Aug. 21, 2020

The U.S. Department Health and Human Services (HHS) rescinded guidance that mandated that lab-developed COVID-19 tests gain approval from the U.S. Food and Drug Administration (FDA) before use, according to a news report from the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota.

"As part of HHS's ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19, the department has determined that the FDA will not require premarket review of laboratory developed tests (LDT) absent notice-and-comment rule making," the HHS said in a document posted to its website.

The decision will allow private and commercial laboratories to manufacture and administer tests, including labs controlled by Quest Diagnostics and LabCorp. According to Politico, most COVID-19 tests currently used in the United States are made by device manufacturers and are subject to FDA review.

LDT’s are typically not used in a pandemic setting, but because of the failed rollout of the Centers for Disease Control and Prevention’s (CDC's) test in February, the FDA loosened restrictions on the tests to increase testing across the country.

Testing has gone down in recent weeks, despite a two-month surge of cases across the Sunbelt. The U.S. recently recorded over 47,000 new COVID-19 cases and more than 1,300 deaths, according to the Johns Hopkins COVID-19 tracker.

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