Biocompatibility Assessment Resource Center

On 18 March 2021 the FDA launched a biocompatibility assessment resource center for medical devices.

This new online resource center 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.