Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Chemical Analysis for Biocompatibility Assessment of Medical Devices." FDA is issuing this draft guidance to describe recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices. The biocompatibility of medical devices is evaluated based on the duration of exposure and nature of contact with the body. Chemical characterization is one approach that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device. This draft guidance is not final nor is it for implementation at this time.