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MD&M West 2025
February 4-6, 2025
We are excited to announce Eurofins EAG Laboratories will exhibit and present at MD&M West in Anaheim February 4-6, 2025, in booth number 2899.
Dr. Philip Ferko, Senior Scientist with EAG, will present in the MD&M West Center Stage at 12pm on February 4.
Presentation Title: Regulatory Update: Game-Changing FDA Guidance for Part 18 Studies
Abstract: Significant changes in the FDA interpretation of chemical characterization under ISO 10993-18 are occurring. In 2024 the FDA released the “Chemicals List for Analytical Performance” and draft guidance “Chemical Analysis for Biocompatibility Assessment of Medical Devices”. The FDA also held a Public Workshop discussing the “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices”. Clearly, the FDA is defining expectations of the Chemical Characterization programs, and the analytical testing labs must adapt to continue producing effective chemical characterization reports. This talk will discuss key changes and relevant questions to ask any analytical laboratory prior to performing chemical characterization work.
View more information about Dr. Ferko’s presentation or contact us to learn more about medical device testing solutions.
We hope to see you there!
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