On November 15, 2021, the Department of Health and Human Services (HHS) announced it would reverse a policy issued in August 2020 prohibiting the Food and Drug Administration (FDA) from requiring a premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations for LDTs during the COVID-19 pandemic.
Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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