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GUIDANCE DOCUMENT

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 December 2014

Download the Final Guidance Document
Final
Docket Number:
FDA-2013-D-0168
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The purpose of this guidance 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 an absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product. Use of these terms may give users allergic to natural rubber latex a false sense of security when using a medical product. FDA is recommending that a consistent, scientifically accurate statement be used by all manufacturers who wish to convey that natural rubber latex was not used as a material in the manufacture of a medical product, its container and/or packaging.

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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-2013-D-0168.

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