lunes, 1 de diciembre de 2014

CDRH Industry: FDA Issues Final Guidance on Recommendations for Labeling Products Not Made with Natural Rubber Latex

Today the Food and Drug Administration (FDA) issued a final guidanceRecommendations for Labeling Medical Products to Inform Users that the Product or Product Container is Not Made with Natural Rubber Latex.”
Contact with medical products containing natural rubber latex can cause a severe, life-threatening, allergic reaction (anaphylaxis) in people allergic to natural rubber latex proteins. Some manufacturers of medical products include statements in their labeling meant to inform users that natural rubber latex, dry natural rubber, or synthetic derivatives of natural rubber latex were not used in the manufacture of a medical product, its container and/or packaging. These labels are not supported by scientific evidence and do not address the potential for accidental contamination with natural rubber latex during or after manufacturing.
Manufacturers should stop using statements such as “latex-free” or “does not contain latex” and instead use the recommended labeling statements, “Not made with natural rubber latex” or “The <name of product or part> is not made with natural rubber latex.” These labels can help FDA staff, health care professionals, patients, and consumers easily identify medical devices and packaging that are not made with natural rubber latex.
The final guidance applies to all FDA regulated medical products for which: 
  • natural rubber latex or synthetic derivatives of natural rubber latex were not used as materials in their manufacture; and
  • any any packaging or container was not made with natural rubber latex or synthetic derivatives of natural rubber latex.      
Examples of medical products that may be affected include:  
  • adhesive bandages
  •  medical diapers
  •  condoms
  •  medical gloves
  • stoppers on vials
  • syringe tip caps
  • sanitary napkins
  • braces/splints
  • crutches
  • medical tape
  • wheelchair seat/tire/brake
  • blood-pressure monitoring cuffs
  • catheters
  • IV bags
  • disposable syringes
  • enema tips
  • molding for orthopedics
If you have any questions regarding this guidance, please contact CDRH’s Division of Industry and Consumer Education (DICE) at, 1-800-638-2041, or 301-796-7100.
Food and Drug Administration
Center for Devices and Radiological Health

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