Town Hall | Virtual
Event Title
Town Hall – Biocompatibility and Chemical Characterization Testing - Extractions
September 23, 2026
- Date:
- September 23, 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 chemical characterization testing methodology to address biocompatibility endpoints for medical devices. Specifically, this town hall will focus on approaches for conducting extractions for chemical characterization testing per ISO 10993-18 and share common issues and examples.
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: September 23, 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 August 26, 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.