title: Medical Devices; General Hospital and Personal Use Devices;   Classification of the Ultraviolet Radiation Chamber Disinfection Device. Final order.
abstract: The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device 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 UV radiation chamber disinfection device 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*; D004203:Disinfection / Q000145:classification* / Q000295:instrumentation*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D014466:Ultraviolet Rays; D014481:United States