FDA final latex skin sensitivity testing guidance revises condom label claims, warnings.
This article was originally published in The Tan Sheet
Executive Summary
FDA FINAL LATEX SENSITIVITY GUIDANCE REVISES LABELING CLAIMS including reduction of the potential for skin reactions. The agency's "final revised draft" allows manufacturers of latex-containing medical products, including natural rubber latex condoms, to carry claims on the reduced potential for inducing chemical sensitization in unsensitized individuals and the reduced potential for eliciting a reaction in sensitized individuals. Comments on the Feb. 13 guidance are due in 30 days.