[Federal Register Volume 71, Number 205 (Tuesday, October 24, 2006)]
[Notices]
[Pages 62269-62271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0400]


Global Harmonization Task Force, Study Groups 1, 2, 4, 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

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availability of several proposed and final documents that have been 
prepared by Study Groups 1, 2, 4, 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 on any of the proposed 
documents by January 22, 2007. After January 22, 2007, 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 240-276-3151. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning the guidances 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 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, 301-443-8913, ext.143.
    For Study Group 2: Mary Brady, GHTF, Study Group 2, Office of 
Surveillance and Biometrics, Center for Devices and Radiological Health 
(HFZ-530), Food and Drug Administration, 1350 Piccard Dr.,Rockville, MD 
20850, 301-594-2102.
    For Study Group 4: Jacqueline Welch, GHTF, Study Group 4, Office of 
Compliance, Center for Devices and Radiological Health (HFZ-320), Food 
and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-
276-0115.
    For 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, 301-594-3090, ext. 207.

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 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 four of the Study Groups (1, 2, 4, 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 
final documents SG1/N15:2006 and SG1/N40:2006.
    SG1/N15:2006 (final document) entitled ``Principles of Medical 
Devices Classification'' assists a manufacturer to assign its medical 
device to an appropriate risk class using a set of harmonized 
principles. This document applies to products that have a medical 
purpose, as described in GHTF document SG1/N29R16:2005 entitled 
``Information Document Concerning the Definition of the Term 'Medical 
Device,''' except for those devices used for the in vitro examination 
of specimens derived from the human body.
    SG1/N40:2006 (final document) entitled ``Principles of Conformity 
Assessment for Medical Devices'' describes the evidence and procedures 
that may be used by a 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. 
This document applies to all products that fall within the definition 
of a medical device, as described in GHTF document SG1/N29R16:2005 
entitled ``Information Document Concerning the Definition of the Term 
'Medical Device,''' except for those devices used for the in vitro 
examination of specimens derived from the human body.
    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 its efforts, this group has 
developed proposed document SG2(PD)/N87R7:2006, and final documents 
SG2/N57R8:2006 and SG2/N79R8:2006.
    SG2(PD)/N87R7:2006 (proposed document) entitled ``An XML Schema for 
the Electronic Transfer of Adverse Event Data Between Manufacturers, 
Authorized Representatives and National Competent Authorities (Based on 
GHTF SG2 N32v5.2)'' provides details of an electronic format for 
manufacturers and National Competent Authorities (NCA) to use when 
exchanging adverse incident data electronically.
    SG2/N57R8:2006 (final document) entitled ``Medical Devices: Post 
Market Surveillance: Content of Field Safety Notices'' identifies 
elements that should be included in safety related notifications issued 
by the medical device manufacturer. SG2/N79R8:2006 (final document) 
entitled ``Medical

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Devices Post Market Surveillance: National Competent Authority Report 
Exchange Criteria and Report Form'' provides guidance, procedures, and 
forms for the exchange of reports concerning the safety of medical 
devices between NCA and other participants of the GHTF National 
Competent Authority Report (NCAR) exchange program.
    Study Group 4 was initially tasked with the responsibility of 
developing guidance documents on quality systems auditing practices. As 
a result of its efforts, this group has developed document SG4/
N30R20:2006. SG4/N30R20:2006 (final document) entitled ``Guidelines for 
Regulatory Auditing of Quality Management Systems of Medical Device 
Manufacturers--Part 2: Regulatory Auditing Strategy,'' which is 
intended to assist medical device regulators and organizations 
conducting quality management system audits to apply a process system 
approach to quality management system requirements (e.g. ISO 13485:2003 
and 21 CFR part 820).
    Study Group 5 was initially tasked with the responsibility of 
developing guidance documents on the content and documentation of 
clinical investigations. As a result of its efforts, this group has 
developed documents SG5(PD)N1R7:2006 and SG5(PD)N2R7.
    SG5(PD)N1R7:2006 (proposed 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(PD)N2R7:2006 (proposed 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 guidances 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: October 16, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-17727 Filed 10-23-06; 8:45 am]
BILLING CODE 4160-01-S