Document ID: FDA-2008-N-0526-0001
Agency: fda
Document Type: Notice
Title: Global Harmonization Task Force, Study Group 1; Proposed Document Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer
Posted Date: 2008-11-19T05:00Z

[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]               
[Page 69665-69666]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no08-94]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0526]

 
Global Harmonization Task Force, Study Group 1; 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 proposed and final documents that have been prepared by 
Study Group 1 of the Global Harmonization Task Force (GHTF). These 
documents represent a harmonized proposal and recommendation from the 
GHTF Study Group 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 
February 17, 2009. After February 17, 2009, 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

[[Page 69666]]

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.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ginette Y. Michaud, Center for Devices 
and Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3700.

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 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 one of the Study Groups (Study Group 1).
    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 SG1(PD)/N055R6:2008 and SG1/N045:2008.
    The proposed document SG1(PD)/N055R6:2008 entitled ``Definitions of 
the Terms Manufacturer, Authorised Representative, Distributor and 
Importer'' provides a harmonized definition of the terms 
``manufacturer,'' ``authorised representative,'' ``distributor,'' and 
``importer''.
    The final document SG1/N045:2008 entitled ``Principles of In Vitro 
Diagnostic (IVD) Medical Devices Classification'' assists a 
manufacturer in allocating an IVD medical device to the appropriate 
risk class by using a set of harmonized classification principles. It 
bases such classification principles on an IVD medical device's 
intended use and allows regulatory authorities to rule upon matters of 
interpretation for a particular IVD medical device, when appropriate.

II. Significance of Guidance

    These documents represent recommendations from the GHTF study group 
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 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: October 22, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-27466 Filed 11-18-08; 8:45 am]

BILLING CODE 4160-01-S