FOOD AND DRUG ADMINISTRATION ISSUES RULE: MICROBIOLOGY DEVICES; RECLASSIFICATION OF ANTIGEN, ANTIBODY, AND NUCLEIC ACID-BASED HEPATITIS B VIRUS ASSAY DEVICES

WASHINGTON, Sept. 18 -- Food and Drug Administration has issued a rule called: Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices.

The rule was published in the Federal Register on Sept. 18 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also esta...