Stay ahead in the diagnostics industry with this targeted course on the FDA’s final order reclassifying qualitative HBV antigen assays, HBV antibody assays, and quantitative HBV nucleic acid-based assays from Class III to Class II, subject to special controls and premarket notification. Learn the actionable compliance steps, understand the new regulatory requirements, and avoid costly enforcement actions. This training is essential for manufacturers, regulatory professionals, and laboratories bringing HBV diagnostic devices to market.
In this course you will learn the following:
* Understand the regulatory background and rationale for the reclassification.
* Identify the new classification and special controls for each HBV assay device type.
* Implement the required steps for compliance, including premarket notification and adherence to special controls.
* Recognize the legal and financial consequences of failing to comply with the final rule.
* Prepare for the effective date and ongoing compliance requirements.
