How Predictive Modeling and Risk-Based Strategy Are Changing What “Defensible” Means
ISO 10993-18 expectations are evolving faster than most extractables and leachables (E&L) programs. The approach that was defensible when you started may not hold up by the time it reaches a reviewer. Programs that meet the minimums but lack scientific rigor are encountering new questions about identification confidence, quantification accuracy, and documentation rationale.¹
This guide is built on patterns observed across hundreds of E&L studies annually at Jordi Labs, an RQM+ company. It shows where programs are most likely to be challenged and how to close those gaps before they become delays.
What You’ll Learn
- What changed in ISO 10993-18:2020 and why regulatory interpretation continues to evolve beyond what the standard captures (e.g., shifting USP chapter expectations²˒³ and FDA interpretations based on submission patterns4)
- How predictive response factor modeling, including Lumo™, uses neural network models to identify unknowns faster5
- When predicted response factors can replace empirical standards, and when they cannot
- How to build documentation that answers regulatory questions on AET calculation, identification confidence, and method selection
- A self-assessment framework to identify misalignment with current expectations
Who This Is For
QA/RA leaders, biocompatibility specialists, and toxicologists responsible for ISO 10993 compliance and E&L program strategy.
References
- International Organization for Standardization. (2020). ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process. https://www.iso.org/standard/64750.html
- United States Pharmacopeia. (2023). USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. https://doi.usp.org/USPNF/USPNF_M7126_03_01.html
- United States Pharmacopeia. (2023). USP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems. https://doi.usp.org/USPNF/USPNF_M7127_03_01.html
- U.S. Food and Drug Administration. (2023). Use of International Standard ISO 10993-1. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and
- Deng, Y., Grice, A., Louis, M., et al. (2026). Neural Network Prediction of Response Factors for Extractables and Leachables in Pharmaceuticals and Medical Devices. PDA Journal of Pharmaceutical Science and Technology. https://journal.pda.org/content/early/2026/01/30/pdajpst.2025-000061.1
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