6 Jun 2025
📦FDA Draft Guidance on Hernia Mesh Package Labeling Recommendations
Hernia Mesh-Package Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Hernia Mesh--Package Labeling Recommendations." This draft guidance provides labeling recommendations for hernia mesh devices that are intended to help promote the safe and effective use of hernia mesh. This draft guidance is not final nor is it for implementation at this time.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance on hernia mesh labeling is significant for manufacturers and healthcare providers, affecting compliance with FDA regulations and potentially influencing device safety protocols. As businesses strive to meet new labeling standards, they must prepare for implementation once the guidance is finalized.