Natural Rubber-Containing Medical Devices; User Labeling

The Food and Drug Administration (FDA) is providing notice that it does not intend to apply to combination products currently regulated under human drug or biologic labeling provisions its September 30, 1997, final rule requiring certain labeling statements for all medical devices that contain or have packaging that contains natural rubber that contacts humans. FDA is taking this action, in part, in response to a citizen petition and other communications from industry that the agency has received since the publication of the final rule. FDA intends to initiate a proceeding to propose natural rubber labeling requirements for drugs and biologics, including combination products that are currently regulated under drug and biologic labeling provisions. Such a proceeding may include a combination of rulemaking and guidance and will offer opportunity for public comment. EFFECTIVE DATE: September 30, 1998. FOR FURTHER INFORMATION CONTACT: Brian L. Pendleton, Center for Drug Evaluation and Research (HFD- 7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5649; or Robert A. Yetter, Center for Biologics Evaluation and Research (HFM-10), Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892, 301-827-0737. SUPPLEMENTARY INFORMATION: In the Federal Register of September 30, 1997 (62 FR 51021), FDA published a final rule to be codified at 21 CFR 801.437 requiring certain labeling statements on medical devices that contain or have packaging that contains natural rubber that contacts humans. The labeling statements alert users that a product contains either dry natural rubber or natural rubber latex, and for products containing natural rubber latex that the presence of this material may cause allergic reactions. The final rule, which becomes effective September 30, 1998, was adopted because natural rubber may cause a significant health risk to persons who are sensitized to natural latex proteins. In response to a comment on the proposed