ACLA President Testifies in Opposition to FDA Intent to Regulate LDTs – Questions Statutory Authority, Cautions Against Duplicative Regulation that Could Stifle Innovation and Compromise Patient Access to Critical Diagnostic Tests

Testifying before the House Energy and Commerce Subcommittee on Health today, Alan Mertz, President of the American Clinical Laboratory Association (ACLA), expressed concern to lawmakers that additional, duplicative regulation imposed by the Food and Drug Administration (FDA) on laboratory-developed tests (LDTs) would cause a harmful ripple effect throughout the laboratory industry that could hamper diagnostic discoveries and preclude patients from timely access to life saving treatments.

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