Microbiology devices; reclassification of herpes simplex virus types 1 and 2 serological assays. Final rule.
The Food and Drug Administration (FDA) is reclassifying herpes simplex virus (HSV) types 1 and/or 2 (HSV 1 and 2) serological assays from class III (premarket approval) to class II (special controls). FDA had earlier proposed this reclassification on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays."
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification; D006561:Herpes Simplex / Q000175:diagnosis*; D006801:Humans; D012698:Serologic Tests / Q000145:classification* / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration; D014773:Virology / Q000295:instrumentation*