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Outcome of LDT Regulation Controversy Defies Forecasting

by | Jul 31, 2015

Few, if any, device regulatory issues are as controversial or as important as FDA’s proposal to regulate Laboratory-Developed Tests (LDTs). If FDA LDT regulation does occur, it would represent the largest change in the regulation of diagnostic tests since Congress enacted the Clinical Laboratory Improvement Amendments (CLIA) in 1988. It would also represent the largest […]

Few, if any, device regulatory issues are as controversial or as important as FDA’s proposal to regulate Laboratory-Developed Tests (LDTs). If FDA LDT regulation does occur, it would represent the largest change in the regulation of diagnostic tests since Congress enacted the Clinical Laboratory Improvement Amendments (CLIA) in 1988. It would also represent the largest […]

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