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SMALL ENTITY COMPLIANCE GUIDE

User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide - Guidance for Industry April 2003

Final
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance is intended to help manufacturers of medical products that contain natural rubber
latex, the majority of whom are small businesses. This guidance addresses specific federal
regulations for labeling medical products that contain natural rubber latex. This guidance does not
apply to products made from synthetic latex or synthetic rubber that do not include natural rubber in
their formulations.

FDA has noted an increase in the number of deaths reported to the agency that are associated with
an apparent sensitivity to natural latex proteins contained in medical devices. FDA’s initial focus
involved deaths following barium enema procedures that were associated with anaphylactic
reactions to the natural rubber latex cuff used on the tip of barium enema catheters. Scientific studies
and case reports have documented sensitivity to natural latex proteins found in a wide range of
medical devices. In order to protect the public health and minimize the risks associated with the use
of natural latex protein sensitivity, FDA has developed a labeling regulation that provides important
information to individuals who are sensitive to natural latex proteins. This rule was published in the
Federal Register of September 30, 1997 (62 FR 51029). This rule was codified in Title 21 of the
Code of Federal Regulations (21 CFR 801.437) and became effective on September 30, 1998.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.