FDA publishes labeling recommendations for hernia mesh: focus on safety and proper device selection
The new FDA guidance proposes improvements in the labeling of surgical hernia mesh, with the aim of reducing adverse events and facilitating device selection by healthcare professionals. Among the recommended data are mesh composition, physical characteristics and mechanical properties. The initiative applies to devices specifically indicated for hernia repair and encourages manufacturers to update the labeling in their submissions to the FDA.
IMDRF Updates Terminology for Reporting Adverse Events in Medical Devices
The IMDRF has released the 2025 update of the terminology for Reporting Adverse Events in Medical Devices, which includes new terms, modifications and removals in various annexes of the document. This revision aims to standardize and improve the reporting of adverse events, so that a globally harmonized classification is used to report and investigate incidents related to medical devices.