Microbiology devices; reclassification of Herpes simplex virus types 1 and 2 serological assays. Direct final rule.
The Food and Drug Administration (FDA) is implementing a direct final rule correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays which FDA was aware of were type 1 and type 2 and, therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.
D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000145:classification; D006561:Herpes Simplex / Q000145:classification* / Q000175:diagnosis; D006801:Humans; D008829:Microbiology / Q000145:classification* / Q000295:instrumentation; D012698:Serologic Tests / Q000145:classification* / Q000295:instrumentation; D012703:Serotyping / Q000145:classification* / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration; D014773:Virology / Q000145:classification / Q000295:instrumentation*