[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Draft Guidance; Availability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availability of the draft guidance document entitled ``Testing for Skin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 This draft guidance is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 The draft guidance, which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 This draft
guidance was reviewed by the General Hospital and Personal Use Devices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ADDRESSES: Written comments concerning the draft guidance must be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copies of the draft guidance to the Division of Small Manufacturers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SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance.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 http://www.fda.gov/
cdrh. The draft guidance entitled ``Testing for Skin Sensitization to
Chemicals in Latex Products'' will be available at http://www.fda.gov/
cdrh/ode/ed_rp.html.
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
