Biocompatibility & Materials Evaluation
FDA's current ISO 10993-1 guidance, finalized September 2023, treats biological evaluation as a risk management exercise, not a fixed test list. Sponsors are expected to weigh existing literature and consensus standards before defaulting to new testing, and chemical characterization data only becomes useful once interpreted against a toxicological threshold.
- ISO 10993 strategy and biological evaluation planning
FDA's current guidance on ISO 10993-1, finalized September 2023, doesn't prescribe a fixed test list. It requires a risk-based rationale, built from your device's materials, manufacturing, and contact profile, for what's tested and what's justified without testing. The guidance also directs sponsors to weigh existing literature, prior FDA review experience, and consensus standards before defaulting to new studies. We build that rationale specifically for your device, not from a generic checklist.
- Biological evaluation plans (BEP) and reports (BER)
A BEP sets the evaluation strategy before testing begins; a BER documents the completed rationale for submission. We prepare both to the standard a reviewer expects, with every test or waiver traceable to a specific risk.
- Chemical characterization, extractables, and leachables
Chemical characterization data is only useful once it's interpreted against a toxicological threshold. We help scope E&L studies to the right analytical methods and materials, then evaluate what the results actually mean for your submission.
- Toxicological risk assessment and materials justification
Raw extractables data doesn't answer a regulatory question on its own, it needs to be weighed against tolerable exposure limits. We perform the toxicological risk assessment that turns analytical results into a defensible safety conclusion.
- CRO protocol scientific review and study design alignment
Testing labs execute protocols; they don't always catch whether the protocol answers the regulatory question your submission actually needs answered. We review CRO protocols before testing begins, when a correction is still cheap.
- Report adequacy review before submission
A completed study report isn't automatically submission-ready. We review test reports against what FDA will expect to see before they go into your file, catching gaps while there's still time to address them.