title: Medical devices; general hospital and personal use monitoring devices; classification of the ingestible event marker. Final order.
abstract: : The Food and Drug Administration (FDA) is classifying the ingestible event marker into class II (special controls). 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: D018795:Device Approval / Q000331:legislation & jurisprudence*; D016903:Drug Monitoring / Q000145:classification / Q000295:instrumentation*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D018670:Monitoring, Ambulatory / Q000145:classification / Q000295:instrumentation*; D008991:Monitoring, Physiologic / Q000145:classification / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration