[Federal Register: September 6, 2002 (Volume 67, Number 173)]
[Notices]
[Page 57026-57027]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se02-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0325]
Medical Devices; Draft Guidance; Medical Devices Made With
Polyvinylchloride Using the Plasticizer di-(2-Ethylhexyl)phthalate;
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availability of the draft guidance entitled ``Medical Devices Made With
Polyvinylchloride (PVC) Using the Plasticizer di-(2-
Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA.''
Through this draft guidance, FDA is proposing to offer suggestions to
manufacturers who fabricate their PVC devices using the plasticizer
DEHP. The guidance recommends ways that manufacturers may reduce or
eliminate potential risks that may be associated with DEHP. This draft
guidance is neither final nor is it in effect at this time.
DATES: Submit written or electronic comments on this guidance by
December 5, 2002.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Medical Devices Made With
Polyvinylchloride (PVC) Using the Plasticizer di-(2-
Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA'' to
the Division of Small Manufacturers, International, and Consumer
Assistance (HFZ-220), Center for Devices and Radiological Health
(CDRH), 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 information on electronic access
to the guidance. Submit written comments concerning this guidance to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Robert Gatling, Center for Devices and
Radiological Health (HFZ-404), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1190.
SUPPLEMENTARY INFORMATION:
I. Background
DEHP is recognized as an important chemical ingredient that affords
PVC many of the physical properties that make the material optimally
suited for use in many of today's medical devices. DEHP is a chemical
whose long-term effects on the human body are unknown. In this draft
guidance, FDA is suggesting that manufacturers label certain devices
with their DEHP content and consider eliminating the use of DEHP in
certain devices that can result in high aggregate exposures in
sensitive patient populations.
FDA recognizes that many devices with PVC containing DEHP are not
used in ways that result in significant human exposure to the chemical.
Therefore, this draft guidance focuses on the small subset of medical
devices where PVC containing DEHP may come in contact with the tissue
of a sensitive patient population in a manner and for a period of time
that may raise concerns about the aggregate exposure to DEHP.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance
represents the agency's current thinking on medical devices made with
PVC using the plasticizer DEHP. 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
In order to receive the ``Medical Devices Made With
Polyvinylchloride (PVC) Using the Plasticizer di-(2-
Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA'' via
your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the
system. At the second voice prompt press 1 to order a document. Enter
the document number (1407) followed by the pound
[[Page 57027]]
sign ([numsign]). Follow the remaining voice prompts to complete your
request.
Persons interested in obtaining a copy of the draft guidance may
also do so using the Internet. CDRH maintains an entry on the Internet
for easy access to information including text, graphics, and files that
may be downloaded to a personal computer with Internet access. Updated
on a regular basis, the CDRH home page includes device safety alerts,
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturer's assistance, information on video
conferencing and electronic submissions, Mammography Matters, and other
device-oriented information. The CDRH Web site may be accessed at
http://www.fda.gov/cdrh. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Dockets Management Branch
Internet site at http://www.fda.gov/ohrms/dockets.
IV. Comments
You may submit to the Dockets Management Branch (see ADDRESSES)
written or electronic comments regarding this draft guidance by
December 5, 2002. You must submit two copies of any comments.
Individuals may submit one copy. You must identify comments with the
docket number found in brackets in the heading of this document. The
draft guidance document and any received comments are available for
public examination in the Dockets Management Branch between 9 a.m. and
4 p.m., Monday through Friday.
Dated: August 28, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-22687 Filed 9-5-02; 8:45 am]
BILLING CODE 4160-01-S