regulatory requirements

What are the key regulatory bodies overseeing histology laboratories?

Various regulatory bodies oversee histology laboratories to ensure compliance with standards and practices. In the United States, the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP) are prominent. The Food and Drug Administration (FDA) also plays a role, particularly concerning laboratory-developed tests (LDTs). Internationally, laboratories may also be regulated by bodies such as the International Organization for Standardization (ISO) and the European Medicines Agency (EMA).

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