Biocompatibility Assessment Resource Center

These resource pages are intended to explain terms and concepts important for the evaluation of biocompatibility of medical devices.  It is not intended to replace any policies specified in Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," also referred to as the FDA’s Biocompatibility Guidance on Use of ISO 10993-1, or other related guidance.

The FDA recommends that you:

• Read the FDA’s Biocompatibility Guidance on Use of ISO 10993-1.
• Follow the steps on this page.
• Refer to applicable device-specific guidance documents and Class II Special Controls Documents for any relevant, device-specific biocompatibility information.

 

Step 1

Biocompatibility Basics

Basics of Biocompatibility

• When biocompatibility info is needed
• What the FDA assesses or evaluates
• How the FDA assesses or evaluates biocompatibility
• Biocompatibility factors of interest to the FDA

Glossary of Biocompatibility Terms 

 

Step 2

Evaluation Endpoints

Biocompatibility Evaluation Endpoint Tables

By Device Category  By Contact Duration
 

 

Step 3

Test Articles

Documenting How a Test Article Compares to the Proposed Medical Device

• Component documentation
• Device documentation
• New processing/sterilization changes
• Formulation changes

 

Step 4

Test Report

What Should I Put in a Test Report?

• Test reports
• Test article preparation
• Test parameters and acceptance criteria
• Analysis of results
• Conclusions

 

For device- and/or submission-specific biocompatibility questions, you may submit a pre-submission, as described in the Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program guidance.

For general biocompatibility questions, you may email CDRH.Biocomp@fda.hhs.gov.