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Guidance on Product Labeling on the Absence of Latex

12/02/2014

Federal Register Notice: FDA is making available a guidance entitled Recommendations for Labeling Medical Products to Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff. Its purpose is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product, product container, and/or packaging. FDA is concerned that statements submitted for inclusion in medical product labeling, such as “latex-free,” “does not contain natural rubber latex,” or “does not contain latex”are not accurate because it is not possible to reliably assure that there is a complete absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product. To download this guidance, click here. To view this notice, click here.

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