[Federal Register: August 23, 2004 (Volume 69, Number 162)]
[Page 51853-51854]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004D-0352]

Global Harmonization Task Force, Study Groups 1 and 2; New 
Proposed Documents; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of two proposed documents that have been prepared by Study 
Groups 1 and 2 of the Global Harmonization Task Force (GHTF). These 
documents are intended to provide information only and represent a 
harmonized proposal and recommendation from the GHTF Study Groups that 
may be used by governments developing and updating their regulatory 
requirements for medical devices. These documents are intended to 
provide information only and do not describe current regulatory 
requirements; elements of these documents may not be consistent with 
current U.S. regulatory requirements. FDA is requesting comments on 
these documents.

DATES: Submit written or electronic comments on any of the documents by 
November 22, 2004. After the close of the comment period, written 
comments may be submitted at any time to the contact persons listed in 
this document.

ADDRESSES: Submit written comments on the documents to the Division of 
Dockets Management (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. 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 Internet, submit written 
requests for single copies on a 3.5'' diskette of the document to the 
Division of Small Manufacturers, International and Consumer 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 ELECTRONIC 
ACCESS section for information on electronic access to these documents.

    For Study Group 1: Ginette Michaud, GHTF, Study Group 1, Office of 
In Vitro Diagnostic Devices (HFZ-440), Center for Devices and 
Radiological Health, Food and Drug Administration, 2098 Gaither Rd., 
Rockville, MD 20850, 301-594-1293, ext. 157;
    For Study Group 2: Stephen Sykes, GHTF, Study Group 2, Office of 
Surveillance and Biometrics (HFZ-500), Center for Devices and 
Radiological Health, Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850, 301-594-3673.


[[Page 51854]]

I. Background

    FDA has participated in a number of activities to promote the 
international harmonization of regulatory requirements. In September 
1992, a meeting was held in Nice, France by senior regulatory officials 
to evaluate international harmonization. At this time it was decided to 
form a GHTF to facilitate harmonization. Subsequent meetings have been 
held on a yearly basis in various locations throughout the world.
    The objective of the GHTF is to encourage convergence at the global 
level of regulatory systems of medical devices in order to facilitate 
trade while preserving the right of participating members to address 
the protection of public health by regulatory means considered most 
suitable. One of the ways this objective is achieved is by identifying 
and developing areas of international cooperation in order to 
facilitate progressive reduction of technical and regulatory 
differences in systems established to regulate medical devices. In an 
effort to accomplish these objectives, the GHTF has formed four study 
groups to draft documents and carry on other activities designed to 
facilitate global harmonization. This notice is a result of documents 
that have been developed by two of the Study Groups (1 and 2).
    Study Group 1 was initially tasked with the responsibility of 
identifying differences between various regulatory systems. In 1995, 
the group was asked to propose areas of potential harmonization for 
premarket device regulations and possible guidance that could help lead 
to harmonization. As a result of their efforts, this group has 
developed SG1(PD)/N043R6. The purpose of SG1(PD)/N043R6 (proposed 
document) ``Labelling (sic) for Medical Devices (revised)'' is to 
describe harmonized requirements for the labeling of medical devices. 
It applies to all products that fall within the definition of a medical 
device that appears within the GHTF document SG1/N029 ``Information 
Document Concerning the Definition of the Term `Medical Device,' '' 
including those products used for the in vitro examination of specimens 
derived from the human body. This document is a revised version of 
previously published guidance on the subject. The new version includes, 
in addition to the original medical device labeling guidance, guidance 
on requirements for labeling of in vitro diagnostic medical devices. 
The new guidance is intended to supersede the previous version of the 
    Study Group 2 was initially tasked with the responsibility of 
developing guidance documents that will be used for the exchange of 
adverse event reports. As a result of their efforts, this group has 
developed SG2(PD)/N38R14. SG2(PD)/N38R14 (proposed document) 
``Application Requirements for Participation in the GHTF National 
Competent Authority Report Exchange Program'' that provides information 
to authorized representatives on prerequisites and commitments required 
from an organization before they can participate in the National 
Competent Authority Report exchange program founded by GHTF SG2.
    These documents represent recommendations from the GHTF Study 
Groups and do not describe regulatory requirements. FDA is making these 
documents available so that industry and other members of the public 
may express their views and opinions.

II. Electronic Access

    Persons interested in obtaining copies of these draft documents may 
also do so using the Internet. Updated on a regular basis, the CDRH 
home page includes device safety alerts, 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh Information on the GHTF may be accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ghtf.org.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding any of these 
documents. 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 these documents. The draft documents and 
received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-19181 Filed 8-20-04; 8:45 am]