Medical Devices; Hematology and Pathology Devices; Classification of the Heparin and Direct Oral Factor Xa Inhibitor Drug Test System
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The Food and Drug Administration (FDA or we) is classifying the heparin and direct oral factor Xa inhibitor drug test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the heparin and direct oral factor Xa inhibitor drug test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Abstract as published in the Federal Register.
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