[Federal Register Volume 78, Number 47 (Monday, March 11, 2013)]
[Notices]
[Pages 15370-15371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05554]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0168]
Draft Guidance for Industry and Food and Drug Administration
Staff: Recommendations for Labeling Medical Products To Inform Users
That the Product or Product Container Is Not Made With Natural Rubber
Latex; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance document entitled ``Draft Guidance
for Industry and FDA Staff: Recommendations for Labeling Medical
Products To Inform Users That the Product or Product Container Is Not
Made With Natural Rubber Latex.'' The purpose of this draft guidance is
to make recommendations on the appropriate language to include in the
labeling of a medical product to convey that natural rubber latex was
not used as a material in the manufacture of the product or product
container. FDA is concerned that statements submitted for inclusion in
medical product labeling such as ``latex-free,'' ``does not contain
natural rubber latex,'' or ``does not contain latex'' are not accurate
because it is not possible to reliably assure that there is an absence
of the allergens associated with hypersensitivity reactions to natural
rubber latex in the medical product. This draft guidance is not final
nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by June 10, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and FDA Staff:
Recommendations for Labeling Medical Products To Inform Users That the
Product or Product Container Is Not Made With Natural Rubber Latex'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments to http://www.regulations.gov. Submit
written comments concerning this draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Michael T. Bailey, Center for Devices
and Radiological Health, Food and Drug
[[Page 15371]]
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G120, Silver
Spring, MD 20993-0002, 301-796-6530, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Contact with devices containing natural rubber has been associated
with anaphylaxis in individuals allergic to natural rubber latex
proteins. FDA medical device regulations include provisions that
require certain labeling statements on medical devices if the device or
device packaging is composed of or contains natural rubber that
contacts humans. (See 21 CFR 801.437.) The biological products
regulations require that the package label or package insert declare
the presence of known sensitizing substances, but do not specifically
mention natural rubber latex (21 CFR 610.61(l)). Specific regulations
for labeling of natural rubber latex content in medical products or
their containers do not exist for drugs or veterinary products.
At this time, there are no regulations requiring the labeling of a
medical product to state that natural rubber latex was not used as a
material in the manufacture of a medical product or medical product
container. However, some manufacturers have included the promotional
statements ``latex-free'' or ``does not contain latex'' in medical
product labeling to inform users that natural rubber latex, dry natural
rubber, or synthetic derivatives of natural rubber latex were not used.
These labeling statements are not sufficiently specific, not
necessarily scientifically accurate and may be misunderstood or applied
too widely, and therefore, it is inappropriate to include such
statements in medical product labeling. Use of these terms may give
users allergic to natural rubber latex a false sense of security when
using a medical product. The draft guidance provides recommendations
for scientifically accurate labeling that can be used by manufacturers
who wish to convey that natural rubber latex was not used as a material
in the manufacture of a medical product or medical product container.
II. Significance of Guidance
This draft guidance document is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the Agency's current thinking on
labeling medical products to inform users that a product or product
container was not made with natural rubber latex. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents also are available at http://www.regulations.gov. To receive
``Draft Guidance for Industry and FDA Staff: Recommendations for
Labeling Medical Products to Inform Users That the Product or Product
Container Is Not Made With Natural Rubber Latex,'' you may either send
an email request to [email protected] for an electronic copy of the
document or send a fax request to 301-847-8149 to receive a hard copy.
Please use the document number 1768 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the
PRA). The collections of information in 21 CFR part 801 are approved
under OMB control number 0910-0485 and the collections of information
in 21 CFR part 610 subpart G are approved under OMB control number
0910-0338.
The labeling provisions recommended in this draft guidance are not
subject to review by OMB because they do not constitute a ``collection
of information'' under the PRA. Rather, the recommended labeling is a
``public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)).
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
VI. Reference
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and are
available electronically at http://www.regulations.gov.
1. Ahmed, S.M., T.C. Aw, and A. Adisesh, ``Toxicological and
Immunological Aspects of Occupational Latex Allergy,'' Toxicological
Reviews, vol. 23, pp. 123-134, 2004.
Dated: March 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05554 Filed 3-8-13; 8:45 am]
BILLING CODE 4160-01-P