[Federal Register: October 28, 1998 (Volume 63, Number 208)]
[Notices]
[Page 57697]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc98-92]

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[[Page 57697]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0878]


Global Harmonization Task Force: Essential Principles of Safety
and Performance of Medical Devices on a Global Basis; Final Working
Draft; 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 a draft document entitled ``Essential Principles of
Safety and Performance of Medical Devices on a Global Basis; Final
Working Draft'' (draft document). This draft document has been prepared
by members of the Global Harmonization Task Force (GHTF), study group 1
on product approval issues and requirements. The draft document is
intended to provide information only and represents a harmonized
proposal. Elements of the approach set forth in this document may not
be consistent with current U.S. regulatory requirements. FDA is
requesting comments on this draft document.

DATES:  Written comments by January 26, 1999. After the close of the
comment period, written comments may be submitted at any time to Kimber
C. Richter (address below).

ADDRESSES:  Submit written comments on the draft document to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be
identified with the docket number found in brackets in the heading of
this document. If you do not have access to the World Wide Web (WWW),
submit written requests for single copies on a 3.5'' diskette of the
draft document entitled ``Essential Principles of Safety and
Performance of Medical Devices on a Global Basis; Final Working Draft''
to the Division of Small Manufacturers Assistance (HFZ-220), Center for
Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your requests, or fax your
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to this draft document.

FOR FURTHER INFORMATION CONTACT: Kimber C. Richter, Office of Device
Evaluation (HFZ-400), Center for Devices and Radiological Health, Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,
301-594-2022.

SUPPLEMENTARY INFORMATION:

 I. Background

     FDA has participated in a number of activities to promote the
international harmonization of regulatory requirements, as described in
an FDA notice on these activities published in the Federal Register of
October 11, 1995 (60 FR 53078). As part of this effort, FDA has been
actively involved since 1992 with GHTF. GHTF has formed four study
groups to draft documents and carry on other activities designed to
facilitate global harmonization. The purpose of this notice is to seek
public comments on a draft document that has been prepared by one of
the GHTF study groups.
    Study group 1 was formed in January 1993 and was originally tasked
with identifying divergence between various regulatory systems. In
1995, the group was asked to propose areas of premarket device
regulation and possible guidances or other documents that could lead to
harmonization of requirements. As a result of their efforts, this group
has developed a draft document entitled ``Essential Principles of
Safety and Performance of Medical Devices on a Global Basis; Final
Working Draft,'' which suggests a minimum harmonized set of
expectations that medical devices worldwide should meet. It is not
intended to exclude country-specific requirements or higher standards
that already exist. It may be used by governments developing new
systems for premarket regulation of devices. This draft document also
provides harmonized language for study group 1 to build on as they
develop further guidance documents, and may ultimately be adapted in
place of country or region-specific language in existing systems.
    The draft document is presented for review and comment so that
industry and other members of the public may express their views
regarding global harmonization of premarket regulation of medical
devices.

 II. Electronic Access

     Persons interested in obtaining a copy of the draft document may
also do so using the WWW. CDRH maintains an entry on the WWW for easy
access to the Web. Updated on a regular basis, the CDRH home page
includes ``Essential Principles for Safety and Performance of Medical
Devices on a Global Basis; Final Working Draft,'' device safety alerts,
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturers' assistance, information on video-
oriented conferencing and electronic submissions, mammography matters,
and other device-oriented information. The CDRH home page may be
accessed at http://www.fda.gov/cdrh.

III. Comments

     Interested persons may, on or before January 26, 1999, submit to
the Dockets Management Branch (address above) written comments
regarding the draft 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 and with the full title of the document. The draft
document and received comments may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
    After January 26, 1999, written comments regarding the draft
document may be submitted at any time to the contact person (address
above).

    Dated: October 1998.
 D.B. Burlington,
 Director, Center for Devices and Radiological Health.
[FR Doc. 98-28833 Filed 10-27-98; 8:45 am]
BILLING CODE 4160-01-F