[Federal Register Volume 73, Number 134 (Friday, July 11, 2008)]
[Notices]
[Pages 39968-39969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15797]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0372]
Global Harmonization Task Force, Study Groups 1 and 5; Proposed
and Final 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 final and proposed documents that have been prepared by
Study Groups 1 and 5 of the Global Harmonization Task Force (GHTF),
respectively. These documents 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 FDA's current regulatory requirements;
elements of these documents may not be consistent with current U.S.
regulatory requirements. In particular, FDA seeks comments on the
advantages and disadvantages of the approaches in the GHTF documents,
particularly where they are not consistent with current practices for
the manufacture of products in the United States.
DATES: Submit written or electronic comments on these documents by
October 9, 2008. After October 9, 2008, written comments or electronic
comments may be submitted at any time to the contact persons listed in
this document.
ADDRESSES: Submit written requests for single copies of these
documents 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 one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 240-276-3151. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the documents.
Submit written comments concerning these 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://www.reguations.gov. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
For information regarding Study Group 1:Ginette Y. Michaud,
Chairperson, GHTF, Study Group 1, Office of Device Evaluation,Center
for Devices and Radiological Health (HFZ-480), Food and Drug
Administration,9200 Corporate Blvd., Rockville, MD 20850, 240-276-3700.
For information regarding Study Group 5:Herbert P. Lerner, GHTF,
Study Group 5, Office of Device Evaluation, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3641.
SUPPLEMENTARY INFORMATION:
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. This meeting led to the
development of the organization now known as the GHTF to facilitate
harmonization. Subsequent meetings have been held in various locations
throughout the world.
The GHTF is a voluntary group of representatives from national
medical device regulatory authorities and the regulated industry. Since
its inception, the GHTF has been comprised of representatives from five
founding members grouped into three geographical areas: Europe, Asia-
Pacific, and North America, each of which actively regulates medical
devices using its own unique regulatory framework.
The objective of the GHTF is to encourage convergence at the global
level of regulatory systems of medical devices 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 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 formed five study groups to draft
documents and carry on other activities designed to facilitate global
harmonization. This notice relates to documents that have been
developed by two of the Study Groups (1 and 5).
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 guidelines that could help
lead to harmonization. As a result of its efforts, this group has
developed final document SG1/N44:2008. SG1/N44:2008 (final document)
entitled ``Role of Standards'' provides information on the use of
standards by a manufacturer when designing a medical device and,
subsequently, when demonstrating that the device conforms to relevant
essential safety and performance criteria.
Study Group 5 was initially tasked with the responsibility of
developing documents on the content and format for clinical
investigation reports and on how to conduct and document a clinical
evaluation. As a result of its efforts, this group has developed
proposed document SG5(PD)/N37:2007. The proposed document SG5(PD)/
N37:2007 entitled ``Clinical Investigations'' introduces general
principles of clinical investigations of medical devices and general
principles when considering the need for a clinical investigation of a
medical device. This document primarily addresses the use of clinical
investigations to support a marketing authorization application.
II. Significance of Guidance
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. In particular, FDA seeks comments
on the
[[Page 39969]]
advantages and disadvantages of the approaches in the GHTF documents,
particularly where they are not consistent with current practices for
the manufacture of products in the United States.
III. Electronic Access
Persons interested in obtaining a copy of these documents may do so
by using the Internet. The Center for Devices and Radiological Health
(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. Information on the GHTF may be accessed at http://www.ghtf.org. The CDRH Web site may be accessed at http://www.fda.gov/cdrh.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding these
documents. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
Dated: July 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15797 Filed 7-10-08; 8:45 am]
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