Federal Register Final rule: FDA is reclassifying hepatitis A virus (HAV) serological assays from Class 3 (premarket approval) into Class 2 (special controls) after reviewing a reclassification petition submitted by Beckman Coulter, Inc. The agency is making available a guidance document entitled Guidance for Industry and FDA Staff: Class 2 Special Controls Guidance Document: Hepatitis A Virus Serological Assays. To view this final rule, click here. To download this guidance, click here.