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The New ISO 10993-18 and Updates to Regulatory Expectations Regarding Chemistry in Support of Medical Device Biocompatibility

Matthew Jorgensen (Chemistry and Materials Scientist, Nelson Laboratories, LLC)

Location: Booth 121

Date: Wednesday, December 4

Time: 1:30pm - 2:15pm

Track: Tech Theater

Format: Presentation

Session Type: Sponsored Session

Vault Recording: TBD

The basic theory of how medical devices should be evaluated for biocompatibility has been in a period of flux. A cornerstone of the new ISO 10993-1:2018 is that evaluation should be focused on a rational and risk-based approach that minimizes unnecessary animal tests. A large part of that approach relies on the use of chemistry and material information to make determinations regarding biocompatibility. Changes to standards (ISO 10993-18) and regulatory policy have complicated this process. This presentation will highlight some key points in the new draft of ISO 10933-18 and provide recent examples implementing these changes in biocompatibility submissions to the FDA.