On September 9, 2026, FDA’s Center for Devices and Radiological Health (CDRH) hosted the first of three town halls focused on biocompatibility and medical devices. This first session focused on recent updates to ISO 10993-1:2025, [...]

On April 16, 2026, FDA’s Center for Devices and Radiological Health (CDRH) issued a Letter to Industry warning manufacturers of CDRH-led combination products about the potential for nitrosamine impurities and outlining what manufacturers should be [...]