Natural rubber-containing medical devices; user labeling--FDA. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule requiring labeling statements on medical devices, including device packaging containing natural rubber that contacts humans. The rule requires labeling of medical devices containing natural rubber latex that contacts humans to state: "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."; labeling of medical devices containing dry natural rubber that contacts humans to state: "This Product Contains Dry Natural Rubber."; labeling of medical devices containing natural rubber latex in their packaging that contacts humans to state: "Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."; labeling of medical devices containing dry natural rubber in their packaging that contacts humans to state: "The Packaging of This Product Contains Dry Natural Rubber."; and that the claim of hypoallergenicity be removed from the labeling of medical devices that contain natural rubber. These requirements are being established in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber.
D003877:Dermatitis, Contact / Q000209:etiology; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D007840:Latex / Q000009:adverse effects*; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D012408:Rubber / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration