[Federal Register Volume 63, Number 208 (Wednesday, October 28, 1998)]
[Notices]
[Pages 57696-57697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28833]


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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