[Federal Register Volume 79, Number 231 (Tuesday, December 2, 2014)]
[Notices]
[Pages 71436-71437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28265]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0168]


Recommendations for Labeling Medical Products To Inform Users 
That the Product or Product Container Is Not Made With Natural Rubber 
Latex; Guidance for Industry and Food and Drug Administration Staff; 
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 guidance entitled ``Recommendations for Labeling 
Medical Products to Inform Users That the Product or Product Container 
Is Not Made With Natural Rubber Latex; Guidance for Industry and Food 
and Drug Administration Staff.'' The purpose of this 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, product 
container, and/or packaging. 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 a complete absence of the allergens associated with 
hypersensitivity reactions to natural rubber latex in the medical 
product.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Recommendations for Labeling Medical Products to Inform Users That 
the Product or Product Container Is Not Made With Natural Rubber Latex; 
Guidance for Industry and Food and Drug Administration Staff'' to the 
Office of the Center Director, Guidance and Policy Development, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments 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 Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G120, Silver Spring, MD 20993-0002, 301-
796-6530, email: [email protected]; or Stephen Ripley, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    Contact with medical products containing natural rubber has been 
associated with anaphylaxis in individuals allergic to natural rubber 
latex proteins. Therefore, all medical devices and device packaging 
composed of or containing natural rubber latex, dry natural rubber, and 
synthetic latex or synthetic rubber that contains natural rubber in the 
formulation are required to include a specific caution statement 
regarding the presence of these materials (e.g., ``Caution: This 
Product Contains Natural Rubber Latex Which May Cause Allergic 
Reactions'') in device labeling (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 and/or packaging 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, medical product 
container, or medical product packaging. 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. FDA believes that these labeling 
statements are not sufficiently specific, not necessarily 
scientifically accurate, and may be misunderstood or applied too widely 
and, therefore, are inappropriate to be included 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. This 
guidance document 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, medical product container, or medical product 
packaging.
    The draft of this guidance was made available in the Federal 
Register on March 11, 2013 (78 FR 15370). The comment period closed on 
June 10, 2013. A number of comments were received from the public, all 
of which the Agency considered carefully as it finalized the guidance 
and made appropriate changes. Any changes to the guidance were minor 
and made to clarify statements in the draft guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on labeling medical products to inform users 
that a product, product container, or product packaging 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 guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Recommendations for Labeling 
Medical Products to Inform Users That the Product or Product Container 
Is Not Made With Natural Rubber Latex; Guidance for Industry and Food 
and Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1768 to identify the guidance you are 
requesting.

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IV. Paperwork Reduction Act of 1995

    This 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 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.

    Dated: November 25, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28265 Filed 12-1-14; 8:45 am]
BILLING CODE 4164-01-P