Town Hall | Virtual
Event Title
Town Hall – Biocompatibility and Toxicological Risk Assessment
October 7, 2026
- Date:
- October 7, 2026
- Time:
- 1:00 p.m. - 2:00 p.m. ET
Summary
The U.S. Food and Drug Administration (FDA) will host a town hall for industry and other interested parties to discuss toxicological risk assessments to address biocompatibility endpoints for medical devices. Specifically, this town hall will discuss methods and issues for conducting toxicological risk assessments to support biocompatibility endpoints per FDA-recognized standards and examples of common deviations.
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 Details
Registration is not required.
Date: October 7, 2026
Time: 1:00 – 2:00 p.m. ET
Platform: Microsoft Town Hall
If you have questions that you wish to submit for possible discussion during the town hall, please email CDRH.Biocomp@fda.hhs.gov. All questions must be received by September 9, 2026, to be considered for the discussion. Questions will not be taken during the town hall.
Event Materials
The presentation, printable slides, and transcript will be 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.