Microbiology devices; reclassification of hepatitis A virus serological assays. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to reclassify hepatitis A virus (HAV) serological assays from class III (premarket approval) into class II (special controls). FDA is taking this action after reviewing a reclassification petition submitted by Beckman Coulter, Inc. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays" that will serve as the class II special control for these devices.
D004869:Equipment Safety; D006506:Hepatitis A / Q000175:diagnosis*; D006801:Humans; D066298:In Vitro Techniques; D008828:Microbiological Techniques / Q000145:classification* / Q000295:instrumentation; D012698:Serologic Tests / Q000145:classification* / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration