[Federal Register: September 6, 2002 (Volume 67, Number 173)]
[Page 57026-57027]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 02D-0325]

Medical Devices; Draft Guidance; Medical Devices Made With 
Polyvinylchloride Using the Plasticizer di-(2-Ethylhexyl)phthalate; 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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availability of the draft guidance entitled ``Medical Devices Made With 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Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA.'' 
Through this draft guidance, FDA is proposing to offer suggestions to 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 This draft 
guidance is neither final nor is it in effect at this time.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Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA'' to 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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.


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 
    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Dockets Management Branch 
Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]