[Federal Register: May 6, 1998 (Volume 63, Number 87)] [Rules and Regulations] [Page 24934-24935] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06my98-8] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 96N-0119] 21 CFR Part 801 Natural Rubber-Containing Medical Devices; User Labeling AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; interpretation. ----------------------------------------------------------------------- SUMMARY: 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 latex labeling regulation (61 FR 32618, June 24, 1996) about the applicability of the requirements to combination products, FDA stated in the preamble to the final rule that it intended to require combination products (i.e., drug/device and biologic/device combinations) that contain natural rubber device components to be labeled in accordance with Sec. 801.437 (62 FR 51021 at 51026). Because the entities that comprise a combination product meet more than one jurisdictional definition, the agency may apply one or more sets of regulatory provisions to such products, as specified in the Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health and the Intercenter Agreement Between the Center for Biologics Evaluation and Research and the Center for Devices and [[Page 24935]] Radiological Health (the Intercenter Agreements). Concerning the implementation of the final rule for these combination products, the FDA stated that natural rubber combination products that are listed in the Intercenter Agreements as being regulated under device labeling provisions will be required to comply with the final rule on the effective date. FDA stated that natural rubber combination products that are listed in the Intercenter Agreements as being regulated under drug or biologic labeling provisions will be subject to the labeling requirements on September 30, 1998, or when FDA amends the Intercenter Agreements to provide that these types of combination products are subject to the requirements, whichever is later. FDA stated that it would provide notice in the Federal Register of the amendments to the Intercenter Agreements to apply the labeling requirements to all natural rubber combination products regulated under drug and biologic provisions. FDA also stated then that: ``the agency anticipates that the Drug/Device Intercenter Agreement will be amended to reflect that prefilled drug vial containers, transdermal patches, infusion pumps, and prefilled syringes that presently are regulated under drug authorities are also subject to this regulation'' (62 FR 51021 at 51026). The agency has received numerous inquiries about, and objections to, the application of the natural rubber labeling requirements to combination drug/device products and to combination biologic/device products that currently are regulated under drug and biologic labeling provisions. These include a citizen petition submitted by the Health Industry Manufacturers Association (Docket No. 98P-0012/CP1). One concern was that some combination products may raise different labeling issues than single-entity device products. In addition, a concern was raised that adequate notice and opportunity for comment was not provided with regard to the applicability of the rule to combination products that currently are regulated under drug and biologic labeling provisions. FDA believes that the notice provided was legally sufficient. However, upon consideration of these comments and the need to provide a uniform labeling approach for all drug and biological products, including combination products currently regulated under drug and biologic labeling provisions, FDA has decided that further opportunity for public comment should be provided on how natural rubber labeling requirements should be applied to all products regulated as drugs and biologics. FDA believes that it would benefit from additional public comment on whether there are labeling issues that are unique to products regulated as drugs and biologics as well as on whether the agency should adopt rules and guidance that would apply to all natural rubber-containing products regulated under the drug and biologic labeling provisions rather than only to combination products. Therefore, FDA is announcing that it does not intend to amend the Intercenter Agreements as stated in the preamble to the final rule. Instead, FDA intends to initiate a proceeding to propose requirements for labeling statements on products regulated as drugs and biologics, including combination products currently regulated under drug and biologic labeling provisions, that contain natural rubber that contacts humans. Such a proceeding may include a combination of proposed rulemaking and guidance and will offer opportunity for public comment. In the interim, FDA is providing notice that it does not intend to apply to combination products 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 containing natural rubber that contacts humans. Dated: April 30, 1998. William B. Schultz, Deputy Commissioner for Policy. [FR Doc. 98-11982 Filed 5-5-98; 8:45 am] BILLING CODE 4160-01-F