Medical devices; clinical chemistry and clinical toxicology devices; classification of the cardiac allograft gene expression profiling test systems.
The Food and Drug Administration (FDA) is announcing the classification of cardiac allograft gene expression profiling 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: Cardiac Allograft Gene Expression Profiling Test Systems." FDA classified 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 announcing the availability of the guidance document that will serve as the special control for this device.
D019963:Clinical Chemistry Tests / Q000145:classification / Q000295:instrumentation; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000145:classification; D020869:Gene Expression Profiling / Q000145:classification* / Q000295:instrumentation; D006084:Graft Rejection / Q000235:genetics; D016027:Heart Transplantation; D006801:Humans; D014116:Toxicology / Q000295:instrumentation; D023001:Transplantation Tolerance / Q000235:genetics; D014481:United States; D014486:United States Food and Drug Administration