[Federal Register Volume 63, Number 85 (Monday, May 4, 1998)]
[Notices]
[Pages 24559-24560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11683]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0191]


Testing for Skin Sensitization to Chemicals in Latex Products; 
Draft Guidance; Availability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availability of the draft guidance document entitled ``Testing for Skin 
Sensitization to Chemicals in Latex Products.'' This draft guidance is 
intended to provide alternative claims for medical devices containing 
natural rubber latex to the ``hypoallergenic'' claim that no longer 
will be acceptable after September 30, 1998. The draft guidance, which 
is not in effect at this time, is being issued for comment. This draft 
guidance was reviewed by the General Hospital and Personal Use Devices 
Panel in September 1997, and it will be posted on the Internet.

DATES: Written comments concerning this guidance must be received by 
August 3, 1998.

ADDRESSES: Written comments concerning the draft guidance must be 
submitted to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 
Comments should be identified with the docket number found in brackets 
in the heading of this document. Submit written requests for singles 
copies of the draft guidance to the Division of Small Manufacturers 
Assistance (DSMA), Center for Devices and Radiological Health (HFZ-
220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send two self-addressed adhesive labels to assist that office in 
processing your request, or fax your request to 301-443-8818. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance.
FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8913.
 SUPPLEMENTARY INFORMATION:

I. Background

    This is the second draft of the guidance entitled ``Testing for 
Skin Sensitization to Chemicals in Latex Products,'' and it replaces 
the July 28, 1997, version that was posted on the Internet and 
distributed by DSMA to manufacturers of medical devices made of natural 
rubber to consumer groups and other agencies of the Federal Government 
for comment. This draft guidance was also discussed during the General 
Hospital and Personal Use Devices Advisory Panel meeting on September 
15, 1997. This second draft incorporates comments received from the 
General Hospital and Personal Use Devices Advisory Panel meeting, 
consumer groups, and medical device manufacturers. This draft guidance 
is intended to provide alternative claims for medical devices 
containing natural rubber latex to replace the ``hypoallergenic'' 
claim. The ``hypoallergenic'' claim will no longer be acceptable after 
September 30, 1998, which is the effective date of the final rule on 
medical devices containing natural-rubber that published in the Federal 
Register of September 30, 1997 (62 FR 51021). This draft guidance also 
includes test methods for supporting these claims. When this draft 
guidance becomes final, the manufacturers of latex containing medical 
devices may use it to address label options and what tests FDA regards 
as appropriate to support statements that replace the current 
``hypoallergenic'' statement.

II. Significance of Guidance

    The draft guidance represents the agency's recommended tests to 
support label claims for reduced chemical sensitivity during use of 
latex products and label options. 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 applicable statute, regulations, or both. The agency has adopted 
Good Guidance Practices (GGP's), which set forth the agency's policies 
and procedures for the development, issuance, and use of guidance 
documents (62 FR 8961, February 27, 1997). This guidance document is 
being issued as a Level 1 guidance consistent with GGP's.

III. Electronic Access

    In order to receive the draft guidance entitled ``Testing for Skin 
Sensitization to Chemicals in Latex Products'' via your fax machine, 
call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 
from a touch-tone telephone. At the first voice prompt press 1 to 
access DSMA Facts, at second voice prompt press 2, and then enter the 
document number (944) followed by the pound sign (#). Then follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the World Wide Web (WWW). The Center for Devices and 
Radiological Health (CDRH) maintains an entry on the WWW for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Web. Updated on a 
regular basis, the CDRH home page includes ``Testing for Skin 
Sensitization to Chemicals in Latex Products,'' device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers addresses), 
small manufacturers' assistance, information on video conferencing and 
electronic submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at <a href="http://www.fda.gov/
cdrh">http://www.fda.gov/
cdrh</a>. The draft guidance entitled ``Testing for Skin Sensitization to 
Chemicals in Latex Products'' will be available at <a href="http://www.fda.gov/
cdrh/ode/ed_rp.html">http://www.fda.gov/
cdrh/ode/ed_rp.html</a>.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 compatible terminal by dialing 1-800-222-0185 
(terminal settings are 8/1/N). Once the modem answers, press

[[Page 24560]]

Enter several times and then select menu choice 1: FDA BULLETIN BOARD 
SERVICE. From there follow instructions for logging in, and at the BBS 
TOPICS PAGE, arrow down to the FDA home page (do not select the first 
CDRH entry). Then select Medical Devices and Radiological Health. From 
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general 
information, or arrow down for specific topics.

IV. Comments

    Interested persons may, on or before August 3, 1998, submit to the 
Dockets Management Branch written comments regarding this guidance 
document. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance document and received comments may be in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: April 14, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-11683 Filed 5-1-98; 8:45 am]
BILLING CODE 4160-01-F