[Federal Register Volume 72, Number 24 (Tuesday, February 6, 2007)]
[Notices]
[Pages 5443-5444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1864]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0031]


Global Harmonization Task Force, Study Groups 1, 2, and 4; New 
Proposed and Final Documents; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of proposed and final documents that have been prepared by 
Study Groups 1, 2, and 4 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 byMay 7, 2007. After May 7, 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 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, 240-276-3700.
    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, 240-276-3458.
    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. 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 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 is a result of documents that have been 
developed by three of the Study Groups (1, 2, 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 document SG1(PD)N044:2006. SG1(PD)N044:2006 (proposed 
document), entitled ``Role of Standards,'' provides guidance on the use 
of standards by a manufacturer when designing a medical device and, 
subsequently, when demonstrating the device conforms to relevant 
essential safety and performance criteria. FDA seeks comment on the 
document and particularly ``Section 5.2 Revision or Replacement of 
Recognised Standards.'' This section addresses the use of a recognized 
standard during the transitional period when it is being replaced by a 
revised version.
    Study Group 4 was initially tasked with the responsibility of 
developing

[[Page 5444]]

guidance documents on quality systems auditing practices. As a result 
of its efforts, this group has developed document SG4(PD)N33R13:2006. 
SG4(PD)N33R13:2006 (proposed document), entitled ``Guidelines for 
Regulatory Auditing of Quality Management Systems of Medical Device 
Manufacturers--Part 3: Regulatory Audit Reports,'' suggests a structure 
for audit reports used in multiple jurisdictions, promoting consistency 
and uniformity and should assist the auditor in preparing a report for 
use by multiple regulators and/or auditing organizations. Having 
reports that are consistent in content should facilitate the review and 
exchange of audit reports. Acceptance of audit reports by multiple 
regulators should eventually reduce the number of audits for 
manufacturers.
    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 developed 
SG2N54R8:2006. SG2N54R8:2006 (final document), entitled ``Medical 
Devices 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. It elaborates on 
the regulatory requirements existing in the participating member 
countries.

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 documents 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 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-1864 Filed 2-5-07; 8:45 am]
BILLING CODE 4160-01-S