Tag Archives: ISO 10993-1

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FDA Updates Guidance on ISO 10993-1 for Evaluation of Biocompatibility  

By MedTech Intelligence Staff
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The FDA has updated its guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in pre-market applications.

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