[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