FDA latex device labeling guidance being modified to standardize test methods.
This article was originally published in The Tan Sheet
Executive Summary
FDA LATEX LABELING GUIDANCE TO BE REVISED TO STANDARDIZE TEST SCORE methodology for latex sensitivity following a review of the document Sept. 15 by the agency's General Hospital & Personal Use Device Panel. Members of the panel said the guidance's scoring techniques for determining whether latex has elicited a reaction in a test subject need clarification.