title: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the continuous glucose monitor secondary display into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language
  for the continuous glucose monitor secondary display’s classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D001786:Blood Glucose; D003626:Data Display / Q000145:classification*; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D008991:Monitoring, Physiologic / Q000145:classification* / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001786:Blood Glucose