Medical devices; clinical chemistry and clinical toxicology devices; drug metabolizing enzyme genotyping system. Final rule.
The Food and Drug Administration (FDA) is classifying drug metabolizing enzyme (DME) genotyping 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: Drug Metabolizing Enzyme Genotyping System." 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.
D000483:Alleles; D001711:Biotransformation / Q000235:genetics; D002624:Chemistry, Clinical / Q000145:classification / Q000295:instrumentation*; D018795:Device Approval; D004798:Enzymes / Q000235:genetics; D004869:Equipment Safety / Q000145:classification*; D020869:Gene Expression Profiling / Q000145:classification* / Q000295:instrumentation*; D005820:Genetic Testing / Q000145:classification; D005838:Genotype; D006801:Humans; D004364:Pharmaceutical Preparations / Q000378:metabolism; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D014116:Toxicology / Q000145:classification / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration
D004798:Enzymes; D004364:Pharmaceutical Preparations; D011933:Reagent Kits, Diagnostic