[Federal Register Volume 72, Number 134 (Friday, July 13, 2007)]
[Notices]
[Pages 38602-38603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13664]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 [Docket No. 2007D-0265]


Global Harmonization Task Force, Study Groups 1 and 5; New 
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 several proposed and final documents that have been 
prepared by Study Groups 1 and 5 of the Global Harmonization Task Force 
(GHTF). 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 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 by October 11, 2007. 
After the 90 day period, 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 the guidance 
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 301-443-8818. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the

[[Page 38603]]

guidance. Submit written comments concerning this guidance 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.fda.gov/dockets/ecomments. 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 Lerner, GHTF, 
Study Group 5, Office of Device Evaluation, Center for Devices and 
Radiological Health (HFZ-410), 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 Global Harmonization 
Task Force (GHTF) to facilitate harmonization. Subsequent meetings have 
been held on a yearly basis 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 their 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 is a result of 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 guidance that could help lead 
to harmonization. As a result of its efforts, this group has developed 
proposed documents SG1(PD)/N045R12:2007 and SG1(PD)/N046R3:2007.
    SG1(PD)/N045R12:2007 (proposed document) entitled ``Principles of 
In Vitro Diagnostic (IVD) Medical Devices Classification'' assists a 
manufacturer to allocate its IVD Medical Device to an appropriate risk 
class using a set of harmonized classification principles based on an 
IVD Medical Device's intended use. This document applies to IVD Medical 
Devices.
    SG1(PD)/N046R3:2007 (proposed document) entitled ``Principles of 
Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices'' 
provides an overview of conformity assessment elements to demonstrate 
conformity to GHTF final document entitled ``Essential Principles of 
Safety and Performance for Medical Devices.'' ``Principles of 
Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices'' 
applies to IVD Medical Devices. It describes the evidence and 
procedures that may be used by the manufacturer to demonstrate that a 
medical device is safe and performs as intended by the manufacturer, 
and the process by which a Regulatory Authority, or Conformity 
Assessment Body, may confirm that the procedures are properly applied 
by the manufacturer.
    Study Group 5 was initially tasked with the responsibility of 
developing guidance 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 
documents SG5/N1R8:2007 and SG5/N2R8:2007.
    SG5/N1R8:2007 (final document) entitled ``Clinical Evidence--Key 
Definitions and Concepts'' introduces the concepts of clinical 
evaluation and clinical evidence, and examines the relationship between 
clinical investigation, clinical data, clinical evaluation, and 
clinical evidence. SG5/N2R8:2007 (final document) entitled ``Clinical 
Evaluation'' provides guidance on how to conduct the clinical 
evaluation of a medical device as part of the conformity assessment 
procedure prior to placing a medical device on the market, as well as 
to support its ongoing marketing.

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.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may also 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. Comments received may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: July 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13664 Filed 7-12-07; 8:45 am]
BILLING CODE 4160-01-S