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LATEX EXAM GLOVE BIOCOMPATIBILITY TESTING REQUIREMENTS

This article was originally published in The Gray Sheet

Executive Summary

LATEX EXAM GLOVE BIOCOMPATIBILITY TESTING REQUIREMENTS will be outlined in an upcoming regulation on labeling for latex- containing medical devices, FDA says in a March 18 letter sent to approximately 800 manufacturers of latex-containing medical devices. FDA says that it "will be indicating" in the Federal Register notice announcing the reg "the need for biocompatibility testing for all latex examination gloves." Biocompatibility testing, comprised of tests for primary skin irritation and dermal sensitization, is currently required for surgical gloves. FDA has not yet determined whether it will require the submission of the latex glove biocompatability data to the agency in 510(k)s. The Federal Register notice will describe several changes in FDA policy on labeling of latex-containing devices. The policy changes are due to increased concern about sensitivity to latex. FDA's March 18 letter notes that since October 1988, the agency has received over 800 adverse reaction reports related to latex- containing products. FDA says that the reports demonstrate "latex in devices poses a significant health risk to some users" and that "users and their health care providers should be informed of its presence" in product labeling. Such labeling, the agency asserts, "will assist physicians when there is a need to create a latex-free environment." The reg will require that firms modify the "principal display panel" for all medical devices containing natural rubber latex that "comes directly or indirectly in contact with the body." The panel must include the statement: "THIS PRODUCT CONTAINS NATURAL RUBBER LATEX." FDA says that manufacturers may expand the statement with additional information on latex allergic reactions if they wish. For example, the agency will not object to the statement: "THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS IN SOME INDIVIDUALS." Under the new reg, FDA also will "no longer permit" the use of terms such as "hypoallergenic" on labels for latex-containing medical devices. The agency believes the term is "inconsistent and misleading...because the basis for the claim, the modified Draize test, is not an appropriate measure of latex sensitivity." New 510(k)s will not be required for labeling modifications on currently marketed products unless the changes made affect the product's safety and efficacy, FDA says. The labeling regulation will become effective six months after publication in the Federal Register. FDA says it is encouraging latex device manufacturers to relabel products voluntarily in the months prior to the effective date. The latex letter was discussed by Byron Tart, chief of the labeling compliance branch of the device center's office of compliance and surveillance, at a March 24-25 Association for the Advancement of Medical Instrumentation (AAMI)/FDA conference on international standards. In a breakout session on device labeling, Tart also noted that the agency is "looking at" the issue of whether latex glove manufacturers can make "powder-free" claims. FDA also is planning to require expiration dating for condoms and latex gloves ("The Gray Sheet" Nov. 30, p. 9). Other labeling initiatives being worked on at OCS include drafting "a uniform statement for condoms and other contraceptive products so that users are aware of whether or not" a product will provide protection against sexually transmitted diseases and HIV. Tart also noted that the device labeling staff is considering how to regulate direct-to-consumer advertising. They are also exploring how to deal with physicians who use devices for off- label uses.
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