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FDA revised latex sensitivity guidance expected in next few months.

This article was originally published in The Tan Sheet

Executive Summary

FDA REVISED LATEX CHEMICAL TESTING GUIDANCE WILL LOWER NUMBER OF PATIENTS required for chemical sensitization testing by one-third to a minimum of 200 subjects. The reduction in patients is among forthcoming changes to the agency's Feb. 13 "final revised draft," entitled "Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Testing for Skin Sensitization to Chemicals in Latex Products." The guidance suggests a negative skin sensitization study include a minimum of 300 nonsensitized subjects ("The Tan Sheet" March 2, p. 12).
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