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US FDA publishes final rule for laboratory developed tests

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US FDA publishes final rule for laboratory developed tests

Apr 29, 2024 7:19 AM

April 29 (Reuters) - The U.S. Food and Drug

Administration (FDA) on Monday published the final rule to

ensure safety and effectiveness of laboratory developed tests

(LDTs), which are designed, manufactured and used within a

clinical laboratory.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shinjini

Ganguli)

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