The End of an Era: USP Class VI Is Being Replaced

USP Class VI is no longer the gold standard. Are you ready for what’s next?

The United States Pharmacopeia (USP) has moved away from traditional Class VI testing. Once regarded as the benchmark for material safety, USP Class VI is now acknowledged as offering limited insight and must be incorporated into a comprehensive, risk-based evaluation strategy aligned with ISO 10993.

What you’ll learn:

• Insights into updated USP chapters 1031, 87, and 88
• A brief overview of the revised test methods
• How the new risk-based approach impacts material qualification
• What this means for regulatory compliance
• Future testing strategies in medical devices and pharmaceutical packaging

Whether you're in regulatory affairs, R&D, or quality assurance, this session will help you stay ahead of the curve and prepare for the future of biocompatibility assessment.