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 1Biocompatibility 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 2Evaluation Endpoints
Biocompatibility Evaluation Endpoint Tables
By Device Category By Contact Duration
Step 3Test Articles
Documenting How a Test Article Compares to the Proposed Medical Device
- Component documentation
- Device documentation
- New processing/sterilization changes
- Formulation changes
Step 4Test Report
What Should I Put in a Test Report?
- Test reports
- Test article preparation
- Test parameters and acceptance criteria
- Analysis of results
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.