FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: HERNIA MESH-PACKAGE LABELING RECOMMENDATIONS; DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, June 6 -- Food and Drug Administration has issued a notice called: Hernia Mesh-Package Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on June 6 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Hernia Mesh-Package Labeling Recommendations." This draft guidance provides labeling recommendations for hernia mesh devices that are intended to help promote the safe and effective use of hernia mesh. This draft guidance is not final nor is it for implementation at th...