Natural Rubber Guidance
FDA assists manufacturers with labeling of devices and packaging containing rubber.
|American Stelmi Corp. (Princeton, NJ) offers elastomeric stoppers as well as |
formulations free of natural rubber latex.
FDA’s Center for Devices and Radiological Health has issued a guidance to assist manufacturers of medical products containing natural rubber latex.
Specifically, the guidance aims to help manufacturers, especially small ones, interpret 21 CFR 801.437, which requires specific labeling statements for use on medical devices or medical device packaging containing natural rubber that comes into contact with humans.
The guidance, “User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide; Guidance for Industry,” published on April 1, 2003, can be viewed in its entirety at www.fda.gov/cdrh/comp/guidance/1212.pdf.
The regulation came about after FDA noticed an increase in the number of deaths associated with patient sensitivity to natural latex proteins. It requires specific statements if the device contains natural rubber latex or dry natural rubber, and if the device packaging contacts humans and contains natural rubber latex or dry natural rubber. It also requires that claims of hypoallergenicity be removed from the labeling of medical devices that contain natural rubber. The rule became effective in 1998.
The guidance offers definitions and clarifications of many of the rule’s provisions, including the following:
• Natural latex is defined as a milky fluid consisting of extremely small particles of rubber obtained from plants and dispersed in an aqueous medium.
• Natural rubber is defined as all materials made from or containing natural latex, usually by the natural rubber latex (NRL) or dry natural rubber (DNR) manufacturing processes.
• The NRL manufacturing process is defined as using natural latex in a concentrated colloidal suspension, forming products by dipping, extruding, or coating.
• The DNR manufacturing process is defined as using coagulated natural latex in dried or milled sheets, forming products by compression molding, extrusion, or converting the sheets into a solution for dipping. Syringe plungers and vial stoppers are usually made from this process.
• The required labeling statement “contains natural rubber” is applicable to a device or package composed of natural rubber or having components formulated from natural rubber. It also must be used on products described as being made of “synthetic latex” or “synthetic rubber” that include natural rubber in their formulations. If there is no natural rubber in the formulation, the statement is not required.
• The required labeling statement “contacts humans” means that the natural rubber in the device or the package is intended to or likely to contact the user or patient. This includes if the device is powdered, or if it is connected to the patient by a liquid path or enclosed gas path.
The guidance also notes that devices with packaging containing natural rubber that contacts humans should contain labeling with one of two statements in bold print, as appropriate. The statements are: “Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions,” or “The Packaging of This Product Contains Dry Natural Rubber.”
Such labeling information must be “prominently and legibly displayed” on all labeling that comes with the device, on the principal display panel of the device packaging, the outside package, the container or wrapper, and the label on the device itself. Devices packaged and sold in bulk dispensing containers would display the statement on the dispensing
container, which in this case is the immediate container.
Exemptions can be considered if a citizen petition is submitted in accordance with 21 CFR 10.30.
Comments and suggestions may be submitted at any time to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061 (HFA-305), Rockville, MD 20852.