New FDA Policy on Lab Developed COVID-19 Tests

Aug. 20, 2020

The U.S. Dept. of Health and Human Services (HHS) yesterday issued a notice, “Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests,” allowing COVID-19 tests developed by individual laboratories to be used without a review or Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA). (Manufacturer developed tests must still receive FDA approval or an EUA.)

The notice states that “the Trump Administration is committed to combating COVID-19, to ensuring that the American people are protected against future pandemics, and to keeping duplicative regulations and unnecessary policies from interfering with those efforts…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 Food and Drug Administration (“FDA”) will not require premarket review of laboratory developed tests (“LDT”)…Those seeking approval or clearance of, or an emergency use authorization (“EUA”) for an LDT may nonetheless voluntarily submit a premarket approval application, premarket notification or an EUA request, respectively, but are not required to do so, and FDA will adjudicate those submissions.”

Earlier this week, the FDA issued a warning about the risk of false positive results with a test kit made by Thermo Fisher Scientific to detect COVID-19 from respiratory specimen. The FDA recommends that clinical laboratories and healthcare providers using the TaqPath COVID-19 Combo Kit promptly implement updates to the software and use instructions, among several recommendations.