US FDA Partial Recognition of ISO 10993-18:2020 Implications

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December 18, 2020


News Alert


US FDA Partial Recognition of ISO 10993-18:2020 – Implications for Biocompatibility Assessment


On July 6, 2020, the US Food and Drug Administration (US FDA) issued a partial recognition of ISO 10993-18:2020, “Chemical Characterization of Medical Device Materials Within a Risk Management Process.”  This standard details a framework for characterizing the:

  • Identities and quantities of the materials used to make a medical device,
  • Chemical constituents in each of these materials,
  • Chemical substances used in the manufacturing process for the device (e.g., processing aids, mold release agents), and
  • Potential of the device (or the materials from which it was made) to release chemical constituents under clinical use conditions (i.e., extractables and leachables) and result in exposures to patients.

For a detailed discussion of the potential implications of US FDA’s partial recognition of this ISO Standard on medical device biocompatibility assessments, see Gradient scientists’ Dr. Joel Cohen and Dr. Rachel Chang summary article in the Society of Toxicology (SOT) Medical Device and Combination Product Specialty Section (MDCPSS) Fall 2020 Newsletter:

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