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GUIDANCE DOCUMENT

Hernia Mesh – Package Labeling Recommendations Draft Guidance for Industry and Food and Drug Administration Staff June 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2025-D-1150
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides FDA’s recommendations on package labeling to support premarket submissions for hernia mesh devices.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.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2025-D-1150.

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