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Recommendations for Labeling Medical Products Without Natural Rubber Latex

This guidance applies to all FDA regulated medical products (devices, drugs, biologics, and veterinary products) where natural rubber latex or its synthetic derivatives were not used in manufacturing the product, its container, or packaging.

  1. Review current product labeling for any “latex-free” or “does not contain latex” statements
  2. Update labeling to use the FDA recommended statement “Not made with natural rubber latex” or component-specific version
  3. Contact appropriate FDA Center for guidance on the regulatory mechanism to update labeling
  4. Consider removing latex-related statements entirely if not necessary
  5. Ensure understanding that no current test methods can guarantee complete absence of latex proteins
  6. Document the basis for any latex-related claims in product labeling

Key Considerations

Non-clinical testing

  • No current analytical methods can identify all proteins and components in natural rubber latex that may lead to allergic reactions
  • Three test methods available (ASTM D5712, ASTM D6499, ASTM D7427) but none can demonstrate complete absence of latex proteins

Labelling

  • Do not use terms “latex-free” or “does not contain latex”
  • Use “Not made with natural rubber latex” for the entire product
  • Use “The [specific component] is not made with natural rubber latex” when referring to specific components
  • Manufacturers should update existing labeling to use the recommended statements or remove latex-free type statements

Safety

  • ASTM D5712: Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and its Products Using the Modified Lowry Method
  • ASTM D6499: Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products
  • ASTM D7427: Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins in Natural Rubber and its Products Derived from Latex

Original guidance

  • Recommendations for Labeling Medical Products Without Natural Rubber Latex
  • HTML / PDF
  • Issue date: 2014-12-02
  • Last changed date: 2019-03-14
  • Status: FINAL
  • Official FDA topics: Medical Devices, Drugs, Animal & Veterinary, Premarket, Biologics
  • ReguVirta summary file ID: c53fc018de3270e125f59c5ad18fa0e7
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