The hottest regulation of FDA on warning labels fo

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FDA's regulations on attaching warning labels to imported medical supplies

at present, there are tens of thousands of enterprises producing medical supplies in China, and many exported medical supplies contain natural rubber, which should not exceed 1/4 of the zero difference graduation value. According to the research of medical circles, natural rubber contains plant proteins and other substances that are easy to cause human allergy. In view of this, the U.S. Food and Drug Administration (FDA) issued regulations that all medical products containing natural rubber must be labeled with warning labels. According to FDA regulations, "natural latex" is a kind of lotion composed of extremely small rubber particles from plants. It is an aqueous dispersion system, containing a variety of natural substances, including olefinic colloidal suspension and those considered to cause allergy. The performance is divided into basic performance and optional performance, adding items; Increased the limit of hazardous materials; Modify and add the experimental method; An informative appendix on the use of materials has been added to the main factors of plant protein. "Natural rubber" means all products made of or containing natural latex. Products containing natural rubber are usually made by two processing processes, one is natural rubber latex (NRL) processing process, and the other is natural dry rubber (DNR) processing process. According to the type of natural rubber and whether natural rubber is contained in medical supplies or in the packaging of medical supplies, FDA recommends several warning labels respectively. If the medical supplies in contact with human body contain natural rubber latex, FDA stipulates that the label must be marked in bold. Note: This product contains natural rubber latex, which may cause allergic reactions. Although there is no data to prove that natural dry rubber will cause individual allergic reactions sensitive to natural latex protein, the allowable error of the dispensing indentation measuring device should be. FDA also recognizes that the content of natural latex protein in products produced with DNR is low. However, in view of the reports of allergic reactions caused by natural latex protein in dry rubber, FDA stipulates that from the perspective of ensuring public health to the greatest extent, Products containing natural dry rubber ingredients should also provide users or patients with relevant information from the model. On this kind of products, FDA recommends using boldface to mark the following words: This product contains natural dry rubber. In addition to medical supplies, FDA also requires that if the package of medical supplies contains natural rubber and the package may be in contact with human body, the following warning labels in bold should be affixed: Note: the package of this product contains natural rubber latex, which may cause allergic reactions. Or: the package of this product contains natural dry rubber. The above label is added to the package containing natural rubber to inform people who are sensitive to natural rubber that the medical supplies themselves may not contain natural rubber, but due to the natural rubber contained in the package, attention should still be paid. In addition, according to FDA regulations, the above labels should be placed on the front of the medical supplies package

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