Hernia Mesh-Package Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Hernia Mesh--Package Labeling Recommendations." This draft guidance provides labeling recommendations for hernia mesh devices that are intended to help promote the safe and effective use of hernia mesh. This draft guidance is not final nor is it for implementation at this time.
Abstract as published in the Federal Register.
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