[Federal Register Volume 63, Number 87 (Wednesday, May 6, 1998)]
[Rules and Regulations]
[Pages 24934-24935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11982]


=======================================================================
-----------------------------------------------------------------------

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