[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]
BILLING CODE 4160-01-S