
[Federal Register: March 25, 2008 (Volume 73, Number 58)]
[Notices]               
[Page 15759-15760]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25mr08-58]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0149] (formerly Docket No. 2007D-0031)

 
Global Harmonization Task Force, Study Group 4; Final Document; 
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 a final document that has been prepared by Study Group 
4 of the Global Harmonization Task Force (GHTF). This document 
represents a harmonized proposal and recommendation from Study Group 4 
of the GHTF that may be used by governments developing and updating 
their regulatory requirements for medical devices. This document is 
intended to provide information only and does not describe current 
regulatory requirements; elements of this document may not be 
consistent with current U.S. regulatory requirements.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document 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 this document 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: Jan Welch, GHTF, Study Group 4, Office 
of Compliance, Center for Devices and Radiological Health (HFZ-320), 
Food

[[Page 15760]]

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 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 a document that has been 
developed by one of the Study Groups (4).
    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/
N33R16:2007. The final document (SG4/N33R16:2007) entitled ``Guidelines 
for Regulatory Auditing of Quality Management Systems of Medical Device 
Manufacturers--Part 3: Regulatory Audit Reports'' provides 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. This document was announced as available for comment on 
February 6, 2007 (72 FR 5443). GHTF received several comments on the 
document proposed on February 6, 2007. In response to the comments, 
GHTF made changes to clarify the document.

II. Significance of Guidance

    This document represents recommendations from the GHTF study groups 
and does not describe regulatory requirements. FDA is making this 
document 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 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. Paperwork Reduction Act of 1995

    For this final document, FDA concludes that there are no collection 
of information requirements under the Paperwork Reduction Act of 1995.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. 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 Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: March 14, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-5927 Filed 3-24-08; 8:45 am]

BILLING CODE 4160-01-S
