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Regulatory Affairs, Medical Devices

Changes to the ISO 10993-23 and its impact on the medical device industry with NAMSA

Posted by on 24 February 2021
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In January 2021, the long-awaited ISO 10993-23 guidance was released; this document will split irritation away from -10 to create a new dedicated in vitro guidance document. Inevitably this change leaves industry with many questions. In this exclusive interview for MedTech TV, Don Pohl, Principal Product Development Strategist at NAMSA, speaks to MedTech Summit Senior Conference Producer Rebecca Brady, about the latest changes to the ISO 10993-23 and its impact on industry.

Don Pohl highlights the impact the new standard will bring to in- vitro testing and provides an outline of where and when these tests can be used for regulatory approval. However, with any new change, comes a certain amount of concern regarding regulatory body acceptance. Don addresses the regulatory bodies concerns, with a focus on the FDA and PMDA, while also providing insight into what industry needs to do to make the most out of the ISO 10093-23. Make sure you check out the full interview to get the latest updates, insights, and advice from leading biocompatibility expert.

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