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Home » FDA’s Policy for Lab-Developed Tests Leaves Unanswered Questions
FDA’s Policy for Lab-Developed Tests Leaves Unanswered Questions
The FDA attempted to provide clarity on an HHS announcement over the summer that it would no longer require premarket reviews of laboratory-developed tests (LDTs), including LDTs for COVID-19, but the attempt just muddied the water further, according to attorneys at Ropes & Gray.
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