Executive Brief: What FDA is Looking For in Your Tox Data to Ensure Safety

Podcast: Let's Talk Risk! Podcast · Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Opublikowano: 2026-10-09

Robust chemical characterization is essentially the gateway to biological safety. A toxicological risk assessment is only as strong as the analytical data supporting it. FDA’s September 2026 biocompatibility town hall provided a detailed look at how the Agency is evaluating chemical characterization and toxicological evidence under ISO 10993-18. The emphasis was not simply on whether testing was performed, but whether the resulting data are sufficiently representative, sensitive, and scientifically justified to support conclusions about biological safety. That expectation reaches well beyond testing. Extraction design, analytical thresholds, device variability, unidentified chemicals, surrogate st...