Issue Date: June 6, 2025
Issued by: Center for Devices and Radiological Health
Topic(s): 510(k), General & Plastic Surgery , Labeling
Status: Draft
Hernia Mesh – Package Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff
This draft guidance document provides FDA’s recommendations on package labeling to support premarket submissions for hernia mesh devices. This guidance applies to certain surgical mesh devices that are intended for hernia repair. The standardized package labeling for hernia meshes recommended in this guidance may provide a more consistent format for disseminating certain clinically relevant information, making it easier for healthcare providers to find certain information needed to use the device safely and for the purposes for which it is intended. These labeling changes may also help mitigate the safety issues for hernia meshes due to suboptimal device selection.
Download the Guidance Document
