Recent U.S. Enforcement Actions Target a Wide Range of Issues for Diagnostic Tests

Aug 13, 2021

Posted by Sidley Austin

U.S. regulators and the public have focused enhanced scrutiny on the use and performance of diagnostics, with that scrutiny only sharpening during the COVID-19 pandemic. Recent enforcement trends have targeted diagnostics (whether approved, cleared, or authorized through an emergency use authorization (EUA)) and laboratories that perform testing and have focused not only on allegations of unlawful marketing but also on the tests’ accuracy. Continue reading

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