In cases where biocompatibility testing may not entirely mitigate medical device risk, chemical characterization data has become increasingly important. The updates to ISO 10993-18:2020 are applying pressure to supply sufficient chemistry data, meaning the industry must apply the concept of the analytical evaluation threshold (AET) to support the advancing methodology of toxicological risk assessments (TRA).
In her latest webinar, Sherry Parker, Senior Director of Regulatory Toxicology at WuXi AppTec Medical Device Testing and international committee member of Technical Committee 194, discusses what medical device manufacturers and regulators need to know to conduct quality toxicological risk assessments (TRA) and shares insights on the upcoming changes to ISO 10993-17. As this guidance development continues, Sherry provides background on the proposed changes, perspective in how the standard continues to define “toxicological risk assessment” and the application of threshold of toxicological concern (TTC).
The industry currently faces a learning curve in what this developing guidance means for medical device testing. Especially with the more exaggerated and exhaustive chemical characterization conditions recommended in ISO 10993-18:2020, and larger extractable chemical profiles, including data-poor substances as a result, testing methodologies are increasingly intricate and complex. Toxicologists, chemists and manufacturers will need to come together to ensure understanding of the potential for patient exposure and develop an appropriate chemical characterization program.
Join Sherry Parker in the webinar, “Toxicological risk assessment of medical devices and proposed updates to 10993-17, including the application of TTC values.”
Established in December 2000, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 4,000 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated”.
For more information, please visit: http://medicaldevice.wuxiapptec.com/
