[Federal Register Volume 71, Number 16 (Wednesday, January 25, 2006)]
[Notices]
[Pages 4148-4150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0011]


Global Harmonization Task Force, Study Groups 1, 2, 3, and 4; 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, 2, 3, and 4 of the Global Harmonization 
Task Force (GHTF). These documents are intended to provide information 
only and 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.

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FDA is requesting comments on these documents.

DATES: Submit written or electronic comments on any of the proposed 
documents by April 25, 2006. After the close of the comment 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 on a 
3.5 diskette 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 
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 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 3: Kimberly Trautman, GHTF, Study Group 3, Office 
of Compliance, Center for Devices and Radiological Health (HFZ-340), 
Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 
240-276-0296.
    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.

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. At this time it was decided to 
form a 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 in order 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 in order 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, 3, and 4).
    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)N015:2005 and SG1(PD)/N040:2005 and final 
documents SG1/N29R16:2005, SG1/N41R9:2005, and SG1/N43:2005.
    SG1(PD)N015:2005 (proposed 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/N29:2005 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/(PD)/N040:2005 (proposed 
document) entitled ``Principles of Conformity Assessment for Medical 
Devices'' 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. This document 
applies to all products that fall within the definition of a medical 
device, as described in GHTF document SG1/N29:2005 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/N29R16:2005 (final document) entitled ``Information Document 
Concerning the Definition of the Term `Medical Device''' describes a 
harmonized definition of a medical device and provides information on 
products that may be considered to be medical devices in some 
jurisdictions. This document applies to products that have a medical 
purpose, including those used for the in vitro examination of specimens 
derived from the human body.
    SG1/N41R9:2005 (final document) entitled ``Essential Principles of 
Safety and Performance of Medical Devices'' is a revised version of 
previously published guidance on the subject and describes the six 
general requirements of safety and performance that apply to all 
medical devices and provides a comprehensive list of design and 
manufacturing requirements of safety and performance, some of which are 
relevant to each medical device. This document applies to all products 
that fall within the definition of a medical device that appears within 
the GHTF document entitled ``Information Document Concerning the 
Definition of the Term `Medical Device,''' including those used for the 
in vitro examination of specimens derived from the human body. The new 
guidance is intended to supersede the previous version of the guidance. 
SG1/N43:2005 (final document) entitled ``Labelling for Medical 
Devices'' describes harmonized principles for the labelling of medical 
devices and recommends harmonized content of labeling such as the 
device identity and intended purpose; how to

[[Page 4150]]

use, maintain and store a device; residual risks; warnings and 
contraindications. This document applies to all products that fall 
within the definition of a medical device that appears within the GHTF 
document SG1/N29:2005 entitled ``Information Document Concerning the 
Definition of the Term `Medical Device,''' including those used for the 
in vitro examination of specimens derived from the human body. The new 
guidance is intended to supersede the previous version of the guidance.
    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 documents SG2(PD)/N54R6:2005, SG2(PD)/N57R6:2005, 
and SG2(PD)/N79R5:2005 and final document SG2/N38R14:2005.
    SG2/(PD)/N54R6:2005 (proposed document) entitled ``Post Market 
Surveillance: Global Guidance for Adverse Event Reporting for Medical 
Devices'' provides guidance on the type of adverse events associated 
with medical devices that should be reported by manufacturers to a 
National Competent Authority (NCA). SG2(PD)/N57R6:2005 (proposed 
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/(PD)/N79R5:2005 (proposed document) entitled 
``Medical 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.
    SG2/N38R15:2005 (final document) entitled ``Application 
Requirements for Participation in the GHTF National Competent Authority 
Report Exchange Program'' describes the prerequisites and commitments 
required from an organization before it can participate in the NCAR 
exchange program founded by GHTF SG2.
    Study Group 3 was initially tasked with the responsibility of 
developing guidance documents on quality systems. As a result of its 
efforts, this group has developed final document SG3/N15R8:2005. SG3/
N15R8:2005 (final document) entitled ``Implementation of Risk 
Management Principles and Activities within a Quality Management 
System'' is intended to assist medical device manufacturers with the 
integration of a risk management system or risk management principles 
and activities into their existing quality management system by 
providing practical explanations and examples. This document assumes a 
basic understanding of quality management system requirements and a 
basic knowledge of quality management system terminology.
    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(PD)/
N30R16:2005. SG4(PD)/N30R16:2005 (proposed document) entitled 
``Guidelines for Regulatory Auditing of Quality Management Systems of 
Medical Device Manufacturers--Part 2: Regulatory Auditing Strategy'' is 
intended to assist medical device regulators and auditing organizations 
conducting quality management system audits of medical device 
manufacturers based on the process approach to quality management 
system requirements (e.g., ISO 13485:2003 and 21 CFR Part 820).

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: January 17, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-846 Filed 1-24-06; 8:45 am]
BILLING CODE 4160-01-S