regulatory considerations

What Are the Key Regulatory Bodies Governing Histology?

Several regulatory bodies oversee histological practices. In the United States, the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) are primarily responsible for regulating clinical laboratories. The Clinical Laboratory Improvement Amendments (CLIA) set forth the standards for laboratory testing, including histology. Internationally, organizations such as the European Medicines Agency (EMA) and the International Organization for Standardization (ISO) play significant roles.

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