The Food and Drug Administration FDA the Agency or we is proposing to reclassify qualitative hepatitis B virus HBV antigen assays qualitative HBV antibody assays and quantitative assays that detect anti-HBs antibodies to HBV surface antigen HBsAg and quantitative HBV nucleic acid-based assays all of which are postamendments class III devices into class II general controls and special controls subject to premarket notification. FDA is also proposing three new device classification regulations along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for each device.