The U.S. Food and Drug Administration (FDA) is hosting a town hall on recent updates to ISO 10993-1 (2025), the standard governing biological evaluation of medical devices. FDA staff will walk through risk assessment approaches for evaluating biocompatibility endpoints, with specific examples covering material-mediated pyrogenicity and systemic endpoints, and will take questions from attendees.

The session is aimed at medical device manufacturers, regulatory affairs staff, and anyone evaluating device biocompatibility. It takes place September 9, 2026 from 1:00 – 2:00 p.m. ET on Microsoft Town Hall. No registration is required , to join the event, click on the link here.