The Food and Drug Administration (FDA) is classifying the prognostic test for assessment of chronic kidney disease progression 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 classification of the prognostic test for assessment of chronic kidney disease progression. We are taking this action because we have determined that classifying the device into class II 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, in part by reducing regulatory burdens.
US Federal Register - FDA Rules · July 24, 2026
FDA Classification of Prognostic Test for Chronic Kidney Disease Progression as Class II Medical Device
Original title: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression
FDA classifies prognostic test for chronic kidney disease progression as Class II device with special controls to ensure safety and effectiveness.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.