HHS Reverses Course on LDTs: COVID-19 LDTs AgainRequire FDA Premarket Review

December 3, 2021By: Steven J Gonzalez Download PDF

On November 15, 2021, the U.S. Department of Health and Human Services (“HHS”) and the Food and DrugAdministration (“FDA”) issued several policy changes governing the regulation of Laboratory Developed Tests(“LDTs”). These changes resume FDA premarket review of COVID-19 LDTs that HHS halted in August 2020 basedon a novel statutory interpretation that FDA lacked legal authority to require premarket review of any LDTs absentnotice-and-comment rulemaking. Developers of COVID-19 LDTs that do not yet have FDA Emergency UseAuthorization (“EUA”) need to be aware of these changes and consider what actions to take in response.

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