Medical device manufacturers producing devices that involve patient contact are required to perform biological safety evaluations, which may include the need for biocompatibility tests to ensure patient safety, as specified by ISO 10993-1.
On June 16, 2016, the U.S. Food & Drug Administration (FDA) officially communicated its guidance to clarify how manufacturers should comply with this standard for evaluation and testing within the risk management process, which became effective in September of 2016.
This updated guidance is firmly established in a risk-based approach and provides detailed recommendations in all aspects of biological safety evaluation. Within this process, chemical characterization helps support the biocompatibility requirements of an evaluation, thereby potentially decreasing turnaround times and development costs, and potentially eliminating the need for certain tests based on achieved results.
We invite you to read this white paper as we discuss:
- The various ways in which chemical characterization and biological risk assessments together can augment and refine the biocompatibility testing process;
- How a well-executed biocompatibility program utilizing specified tools can create significant time and cost efficiencies; and
- The importance of using a testing guide, such as NAMSA’s matrix tool, to determine when a suitable series of tests are needed to further support the characterization of materials to effectively address overall biological product safety.
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