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Zdrowie i gospodarka · 16/09/2024

FDA Classifies Pediatric Continuous Renal Replacement Therapy System into Class II with Special Controls

The US Food and Drug Administration (FDA) is classifying the pediatric continuous renal replacement therapy system into Class II, requiring special controls, to ensure its safety and effectiveness. This move aims to improve patients' access to innovative devices.

Source: Federal Register — Food and Drug AdministrationOpen original release →