Are you preparing for the changes to USP Class VI testing?

For decades, USP Class VI testing (USP 88) has been a recognized benchmark for assessing the biological safety of polymers and other materials used in medical and pharmaceutical applications. It has offered manufacturers a way to demonstrate compliance and reassure customers about the safety of their components.

But as industry expectations evolve, many experts and laboratories are beginning to question whether USP Class VI, in its current form, is the best path forward.

A Shift Away from Animal Testing

One of the main drivers of this discussion is the movement to reduce reliance on animal testing. Nelson Labs and other thought leaders in the field have noted that much of USP Class VI testing relies on in vivo models that may no longer align with today’s regulatory and ethical priorities.

In fact, the industry is exploring greater use of in vitro methods—such as cytotoxicity assays (USP 87)—which can provide reproducible data without involving animal testing. These methods may also fit better within a risk-based evaluation framework, something regulators increasingly encourage.

Toward Risk-Based, Internationally Aligned Testing

Another factor is the growing push for global harmonization. Many international markets already look to the ISO 10993 series as their primary guidance for biocompatibility, which emphasizes a broader, context-driven approach rather than a single pass/fail standard. Aligning more closely with ISO expectations could help companies streamline compliance across multiple geographies.

What This Means for Industry

While USP Class VI remains widely referenced, it’s worth considering how the standard fits into the broader landscape. Rather than treating it as the final word in biocompatibility, many organizations are beginning to see it as one piece of a larger evaluation strategy.

Forward-looking companies may want to track these developments and begin preparing for a future where risk-based assessments, chemical characterization, and in vitro methods take on a larger role in customer and regulatory conversations.

Reference

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