Beyond Biocompatibility: 10993-1 & FDA Expectations for Particulate Evaluation in Vascular Devices

Recent updates to ISO 10993-1 and evolving FDA feedback are raising the bar for particulate evaluation in vascular medical devices. What was once a secondary consideration is now becoming a critical factor in regulatory submissions and device safety assessments. This webinar will break down the regulatory drivers behind the shift, explain the practical implications for manufacturers, and outline best practices for designing and executing robust particulate testing strategies that satisfy both international and FDA expectations. Attendees will gain actionable insights into how to adapt their development and regulatory pathways to stay compliant and competitive in this changing landscape.

By the end of this session, participants will be able to:
• Understand the key changes in ISO 10993-1 and recent FDA feedback that emphasize particulate characterization.
• Identify when and why particulate evaluation is required for vascular devices, including stents, catheters, tubing sets, IV bags, and delivery systems.
• Differentiate between traditional biocompatibility endpoints and the emerging particulate-specific requirements.
• Apply best practices in test method selection, validation, and risk assessment for particulate analysis.
• Prepare stronger regulatory submissions that proactively address FDA expectations and minimize review delays.