Medical devices; immunology and microbiology devices; classification of cystic fibrosis transmembrane conductance regulator gene mutation detection system. Final rule.
The Food and Drug Administration (FDA) is classifying the cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection 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: CFTR Gene Mutation Detection 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 announcing the availability of the guidance document that will serve as the special control for the device.
D003550:Cystic Fibrosis / Q000175:diagnosis*; D018795:Device Approval; D019719:Diagnostic Equipment / Q000145:classification*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D007158:Immunologic Techniques / Q000145:classification / Q000295:instrumentation*; D009154:Mutation / Q000276:immunology; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration
D011933:Reagent Kits, Diagnostic