title: Medical Devices; Ophthalmic Devices; Classification of the   Diurnal Pattern Recorder System. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the diurnal pattern recorder system 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 diurnal pattern recorder system'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: D018795:Device Approval / Q000331:legislation & jurisprudence*; D003941:Diagnostic Techniques, Ophthalmological / Q000145:classification* / Q000295:instrumentation*; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D007429:Intraocular Pressure; D008991:Monitoring, Physiologic / Q000145:classification / Q000295:instrumentation; D009885:Ophthalmology / Q000145:classification* / Q000295:instrumentation*; D013686:Telemetry / Q000145:classification / Q000295:instrumentation; D014481:United States