In this conversation, Anne and Dia Hill discuss the FDA's final rule on laboratory developed tests (LDTs), focusing on the implications for the industry, the shift in regulation, and the challenges laboratories face in compliance. They explore the phased implementation timeline, the need for training and resources, and the importance of regulatory assessments and classification of tests. The conversation highlights the global implications of these regulations and the necessity for laboratories to adapt to new quality systems and oversight requirements.

Ver todos los episodios