title: Medical devices; neurological devices; classification of the brain injury adjunctive interpretive electroencephalograph assessment aid. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the brain injury adjunctive interpretive electroencephalograph assessment aid 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 brain injury adjunctive interpretive electroencephalograph assessment aid'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: D001930:Brain Injuries / Q000175:diagnosis*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D003936:Diagnosis, Computer-Assisted / Q000295:instrumentation*; D003943:Diagnostic Techniques, Neurological / Q000145:classification / Q000295:instrumentation*; D004569:Electroencephalography / Q000295:instrumentation*; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D014481:United States