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ARUP Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices

ARUP Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
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New-york , United-states , Jonathan-genzen , Andy-theurer , Jonathan-carr , York-state-clinical-laboratory-evaluation-program , Rule-to-regulate-laboratory , Centers-for-medicare , Medicaid-services-clinical-laboratory-improvement-amendments , Department-of-pathology , Institute-for-research , University-of-utah

ARUP Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices

/PRNewswire/ A final FDA rule regulating laboratory-developed tests (LDTs) as medical devices does not address serious concerns raised by ARUP Laboratories.

New-york , United-states , Jonathan-genzen , Jonathan-carr , Andy-theurer , University-of-utah , Department-of-pathology , York-state-clinical-laboratory-evaluation-program , Centers-for-medicare , Medicaid-services-clinical-laboratory-improvement-amendments , Institute-for-research , Medical-device-amendments