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Regulatory News | 01 December 2014 | By Alexander Gaffney, RAC
US regulators have finalized a policy recommending that medical device companies label their products with a specific warning if they are manufactured using natural rubber latex (NRL) proteins.
NRL is found in numerous medical products, most prominently latex gloves, vial stoppers and condoms, and is noted for its elastic properties. However, repeated or prolonged exposure to NRL can result in patients developing allergies or sensitivity to NRL, generally in the form of skin-site reactions.
In light of these concerns, some manufacturers have moved to using latex alternatives, and have taken to the habit of labeling these products as "latex-free" or with statement indicating that the product "does not contain natural rubber latex."
But as FDA observed in a draft guidance issued in March 2013, those statements aren't always accurate.
"The terms 'latex-free' and 'does not contain natural rubber latex' suggest that the medical product is completely without NRL," FDA wrote. "However, even when medical products are not made with NRL, there is a chance that products can become contaminated with NRL allergens during manufacturing or packaging processes." FDA is also unaware of any test method capable of detecting the absence of latex proteins capable of causing allergic reactions.
In other words, if someone is allergic to NRL, even products currently labeled as "latex-free" or not containing NRL can cause allergic reactions and anaphylaxis.
To read more about the natural rubber latex labeling draft guidance document, please see our story here.
FDA is now out with a final guidance document—nearly identical to the draft guidance—calling on medical device manufacturers to use only approved labeling statements.
The statement "not made with natural rubber latex" should only be used if neither NRL nor synthetic NRL derivatives were used to manufacture a device, FDA explains in its guidance.
Qualifications are necessary if the device, its packaging or its container use NRL or NRL derivatives. In such cases, the manufacturer should state which component is not made with natural rubber latex or synthetic natural rubber latex.
"These statements … communicate that natural rubber latex was not used as a material in the finished product or as a material in a specific component, respectively," FDA explained. "At the same time, the statement does not make the unsupportable claim that the medical product is 'free' of or 'does not contain' natural rubber latex (i.e., materials or contamination), which may promote a false sense of safety to users who are allergic to natural rubber latex."
Sponsors of products currently labeled with statements like "latex-free" or "does not contain latex" should update their labeling to adopt FDA's new recommendations, the agency said.
Edit: In addition to medical device companies, the guidance also applies to manufacturers of pharmaceuticals, biologics and veterinary products. Those products are sometimes stored in containers made with latex, FDA noted.
Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex (FR)
Tags: Latex, Natural Rubber Latex, Guidance, Final Guidance