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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)...
United StatesFood, Drugs, Healthcare, Life Sciences
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.