New online resources include step-by-step recommendations for biocompatibility evaluations for medical devices

If your email program has trouble displaying this email, view as a webpage. FDA Launches Biocompatibility Assessment Resource Center Today, the U.S. Food and Drug Administration (FDA) launched an online Biocompatibility Assessment Resource Center. This new online resource includes explanations of important terms and concepts related to medical device biocompatibility and step-by-step recommendations compiled from existing FDA guidance for how best to use the FDA's existing resources about medical device biocompatibility assessments when preparing medical device submissions to the FDA. The step-by-step recommendations include: Basics of Biocompatibility Biocompatibility Endpoint Tables Documenting How a Test Article Compares to the Proposed Medical Device What Should I Put in a Test Report? This resource is not intended to replace any policies specified in an FDA guidance. Read More Questions? If you have questions about the Biocompatibility Assessment Resource Center, email CDRH.Biocomp@fda.hhs.gov.

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