Medical devices; clinical chemistry and clinical toxicology devices; instrumentation for clinical multiplex test systems. Final rule.
The Food and Drug Administration (FDA) is classifying instrumentation for clinical multiplex test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems." 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. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
D002624:Chemistry, Clinical / Q000145:classification / Q000295:instrumentation*; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D012815:Signal Processing, Computer-Assisted / Q000295:instrumentation*; D014116:Toxicology / Q000145:classification / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration