This guidance aims to improve safety evaluations and aligns with ISO 10993 standards, facilitating comprehensive risk assessment and regulatory compliance. It provides recommendations for collecting and reporting chemical characterization data to support two key activities:
- Screening for Extractables: This encompasses both non-targeted (unspecified) and targeted (specified) analyses to assess biocompatibility endpoints, including various toxicity types and genotoxicity, alongside toxicological risk assessment (TRA).
- Chemical Equivalency Comparison: This involves comparing the chemical properties of a new device with those of an existing device that has established biocompatibility.
While these methods apply to most devices, specific categories like ophthalmic or respiratory devices may need different approaches due to unique materials or practices. Additionally, if necessary, research simulating the clinical use of the device can enhance the toxicological risk assessment (TRA) and update the exposure estimate. Note that leachables and simulated-use studies are not covered in this guidance.
More information can be found in the annexes of this draft guideline, which discuss data gathering, extraction conditions, chemical analysis, extractables profiling, and data reporting.
References:
Chemical Analysis for Biocompatibility Assessment of Medical Devices