[Federal Register: August 23, 2004 (Volume 69, Number 162)]
[Notices]
[Page 51853-51854]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au04-54]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
[[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
guidance.
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]
BILLING CODE 4160-01-S