[Federal Register: July 13, 2007 (Volume 72, Number 134)]
[Notices]
[Page 38602-38603]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jy07-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0265]
Global Harmonization Task Force, Study Groups 1 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
availability of several proposed and final documents that have been
prepared by Study Groups 1 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 by October 11, 2007.
After the 90 day 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 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
[[Page 38603]]
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 information regarding 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 information regarding 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, 240-276-3641.
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 documents that have been
developed by two of the Study Groups (1 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
proposed documents SG1(PD)/N045R12:2007 and SG1(PD)/N046R3:2007.
SG1(PD)/N045R12:2007 (proposed document) entitled ``Principles of
In Vitro Diagnostic (IVD) Medical Devices Classification'' assists a
manufacturer to allocate its IVD Medical Device to an appropriate risk
class using a set of harmonized classification principles based on an
IVD Medical Device's intended use. This document applies to IVD Medical
Devices.
SG1(PD)/N046R3:2007 (proposed document) entitled ``Principles of
Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices''
provides an overview of conformity assessment elements to demonstrate
conformity to GHTF final document entitled ``Essential Principles of
Safety and Performance for Medical Devices.'' ``Principles of
Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices''
applies to IVD Medical Devices. It 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.
Study Group 5 was initially tasked with the responsibility of
developing guidance documents on the content and format for clinical
investigation reports and on how to conduct and document a clinical
evaluation. As a result of its efforts, this group has developed
documents SG5/N1R8:2007 and SG5/N2R8:2007.
SG5/N1R8:2007 (final 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/N2R8:2007 (final 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 guidance 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ghtf.org The CDRH web site may be accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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: July 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13664 Filed 7-12-07; 8:45 am]
BILLING CODE 4160-01-S