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.
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.