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FDA latex sensitivity claims guidance will be discussed Sept. 15-16 by advisory panel.

This article was originally published in The Tan Sheet

Executive Summary

LATEX SKIN SENSITIZATION CLAIMS GUIDANCE SLATED FOR REVIEW BY FDA PANEL Sept. 15-16. The agency's General Hospital & Personal Use Devices Advisory Panel will convene to provide feedback on FDA's July 28 draft guidance on 510(k)s (abbreviated approvals) for testing skin sensitization to chemicals in latex products. The one-and-a-half day meeting will entail detailed review of the guidance by the advisory group, with at least two hours allocated for industry comments and public input.
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