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FDA Issues Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices

Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices.

This draft guidance, once finalized, is intended to describe recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices. The draft guidance is also intended to improve consistency and reliability of analytical chemistry studies submitted as part of premarket submissions to demonstrate device biocompatibility.

Note: This guidance is not for implementation at this time.

Submit comments on this draft guidance

Submit comments under docket number FDA-2024-D-4165 at www.regulations.gov by November 18, 2024 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.

Questions?

If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.