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Zdrowie i gospodarka · 05/09/2024

FDA Classifies Heparin and Direct Oral Factor Xa Inhibitor Drug Test System as Class II Device

The FDA has classified the heparin and direct oral factor Xa inhibitor drug test system as a Class II device, requiring special controls to ensure its safety and effectiveness, with the goal of enhancing patient access to innovative devices.

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