Town Hall | Virtual
Event Title
Town Hall – Biocompatibility Risk Assessment
September 9, 2026
- Date:
- September 9, 2026
- Time:
- 1:00 p.m. - 2:00 p.m. ET
Summary
The U.S. Food and Drug Administration (FDA) held a town hall for industry and other interested parties to discuss recent updates to ISO 10993-1(2025), “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” and share risk assessment approaches for evaluating biocompatibility endpoints for medical devices, with specific examples for evaluating material-mediated pyrogenicity and systemic endpoints.
Background
Medical devices that come into direct contact or indirect contact with the human body should be evaluated for the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. Manufactures routinely evaluate biocompatibility endpoints using a risk-based framework per FDA’s guidance titled “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'.”
It is the intention of FDA to assess biocompatibility in a way that is least burdensome for both industry and FDA reviewers.
Event Materials
The presentation, printable slides, and transcript are available on this webpage and at CDRH Learn under “Specialty Technical Topics,” sub-section “Biocompatibility.”
If you have questions about this town hall, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.