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Latex allergy device labeling proposal would give firms choice of three labeling statements.

This article was originally published in The Gray Sheet

Executive Summary

INPUT ON LATEX ALLERGY RISK COMMUNICATION TO DEVICE USERS is sought by FDA in a proposed rule slated to be published in the June 24 Federal Register. In the proposal, which would require devices containing natural latex to include a labeling statement on the risk of allergic reaction, FDA requests comments on how it can "best ensure that the message that the regulation is intended to convey reaches the ultimate user." FDA is interested in user education to augment labeling requirements because some of the devices that would be affected by the reg "may be sold in bulk packages which are then divided up and used individually," the agency explains.



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