Document ID: FDA-2013-D-0168-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Staff; Availability: Recommendations for Labeling Medical Products to Inform Users the Product or Product Container Is Not Made With Natural Rubber Latex
Posted Date: 2013-03-11T04:00Z

[Federal Register Volume 78, Number 47 (Monday, March 11, 2013)]
[Notices]
[Pages 15370-15371]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance document entitled ``Draft Guidance 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 The purpose of this draft guidance is 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 This draft guidance is not final 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance for Industry and FDA Staff: 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, Michael.Bailey@fda.hhs.gov.

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 dsmica@fda.hhs.gov 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