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FDA

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15 May 24

FDA Final Rule | Labshire

By James Blackwell, President, Windshire Group, LLC and Labshire, LLC May 14, 2024 Download this White Paper here | FDA Final Rule IVDs | Labshire.com  May 2024 As we anticipated and reported in February, the FDA issued a final rule amending its regulations to state explicitly that in vitro diagnostic…
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Lab Developed Tests – Are You Ready?

SITUATION The U.S. Food and Drug Administration (FDA) recently proposed a rule to increase oversight of laboratory-developed tests (LDTs). 21 CFR 809 In Vitro Diagnostic Products for Human Use was passed by Congress in 1976 to provide a means for regulating commercially developed laboratory test systems. At that time many…
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