Issue Date: April 1, 2003
Issued by: Center for Devices and Radiological Health
Topic(s): Radiological Health
Status: Final
User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide – Guidance for Industry
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.
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