Rachael Grey

Rachael Grey

Epstein Becker & Green

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A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule

Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase 1 expectations under FDA’s Laboratory Developed Tests Final Rule (the “LDT Final...more

2/27/2025  /  Clinical Laboratories , Compliance , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Regulatory Requirements , Reporting Requirements
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