Regulatory initiatives for natural latex allergy: US perspectives

The US Food and Drug Administration (FDA) has regulatory authority over foods, human drugs, cosmetics, medical devices, radiological products, biologics, and veterinary products. Among these products, FDA believes that the use of medical devices, including medical gloves, condoms, catheters, and bre...

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Bibliographic Details
Published in:Methods (San Diego, Calif.) Calif.), 2002-05, Vol.27 (1), p.87-92
Main Authors: Farnham, John J, Tomazic-Jezic, Vesna J, Stratmeyer, Mel E
Format: Article
Language:English
Subjects:
Allergy
Equipment and Supplies
Gloves, Surgical
Humans
Latex Hypersensitivity - prevention & control
Medical devices
Natural latex
Natural rubber
Regulation
Social Control, Formal
United States
United States Food and Drug Administration - legislation & jurisprudence
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Summary:The US Food and Drug Administration (FDA) has regulatory authority over foods, human drugs, cosmetics, medical devices, radiological products, biologics, and veterinary products. Among these products, FDA believes that the use of medical devices, including medical gloves, condoms, catheters, and breathing bags, represents the greatest source of natural latex proteins to exposed individuals. A medical device is defined in the Federal Food Drug and Cosmetic Act (FFDCA) as an instrument, apparatus, implement, machine, etc., that is intended for use in the diagnosis or treatment of disease or is intended to affect the structure or any function of the body of a human or other animal, and that does not achieve any of its principal intended purposes through chemical action in the body. This article provides some brief, general background about FDA's medical device regulatory process and then addresses the issue of natural latex allergy. Finally we discuss the steps the Agency has taken to evaluate the magnitude and nature of the problem, and FDA's efforts to assist manufacturers, health professionals, and others in minimizing exposure and sensitization to natural latex proteins in medical devices.
ISSN:1046-2023
1095-9130
DOI:10.1016/S1046-2023(02)00056-7