Global Harmonization Task Force, Study Groups 1 and 5; Proposed and Final Documents; Availability, 39968-39969 [E8-15797]
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39968
Federal Register / Vol. 73, No. 134 / Friday, July 11, 2008 / Notices
certificate not less than annually. FDA
is not calculating this small fee as cost
of doing business because it is less than
or equal to the biannual courier costs
the registrant incurs for paper
submissions.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.fda.gov/cder/guidance/index.htm,
https://www.fda.gov/cber/
guidelines.htm, https://www.fda.gov/
cvm/guidance/guidance.html, and
https://www.regulations.gov.
Dated: July 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15801 Filed 7–10–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. FDA–2008–D–0372]
Global Harmonization Task Force,
Study Groups 1 and 5; Proposed and
Final Documents; Availability
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of final and proposed
documents that have been prepared by
Study Groups 1 and 5 of the Global
Harmonization Task Force (GHTF),
respectively. 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 FDA’s current
regulatory requirements; elements of
these documents may not be consistent
with current U.S. regulatory
requirements. In particular, FDA seeks
comments on the advantages and
disadvantages of the approaches in the
GHTF documents, particularly where
they are not consistent with current
practices for the manufacture of
products in the United States.
DATES: Submit written or electronic
comments on these documents by
October 9, 2008. After October 9, 2008,
written comments or electronic
comments may be submitted at any time
to the contact persons listed in this
document.
VerDate Aug<31>2005
17:19 Jul 10, 2008
Jkt 214001
Submit written requests for
single copies of these 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 selfaddressed 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
documents.
Submit written comments concerning
these documents to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.reguations.gov. Identify comments
with the docket number found in
brackets in the heading of this
document.
ADDRESSES:
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 P. Lerner, GHTF,
Study Group 5, Office of Device
Evaluation, Center for Devices and
Radiological Health (HFZ–470),
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 GHTF to
facilitate harmonization. Subsequent
meetings have been held 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.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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
relates to 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 guidelines that
could help lead to harmonization. As a
result of its efforts, this group has
developed final document SG1/
N44:2008. SG1/N44:2008 (final
document) entitled ‘‘Role of Standards’’
provides information on the use of
standards by a manufacturer when
designing a medical device and,
subsequently, when demonstrating that
the device conforms to relevant
essential safety and performance
criteria.
Study Group 5 was initially tasked
with the responsibility of developing
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 proposed
document SG5(PD)/N37:2007. The
proposed document SG5(PD)/N37:2007
entitled ‘‘Clinical Investigations’’
introduces general principles of clinical
investigations of medical devices and
general principles when considering the
need for a clinical investigation of a
medical device. This document
primarily addresses the use of clinical
investigations to support a marketing
authorization application.
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. In
particular, FDA seeks comments on the
E:\FR\FM\11JYN1.SGM
11JYN1
Federal Register / Vol. 73, No. 134 / Friday, July 11, 2008 / Notices
advantages and disadvantages of the
approaches in the GHTF documents,
particularly where they are not
consistent with current practices for the
manufacture of products in the United
States.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Electronic Access
Guidance for Industry and Food and
Drug Administration Staff; Surveillance
and Detention Without Physical
Examination of Condoms; Availability
Persons interested in obtaining a copy
of these documents 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 https://www.ghtf.org. The
CDRH Web site may be accessed at
https://www.fda.gov/cdrh.
IV. Comments
pwalker on PROD1PC71 with NOTICES
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. 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 Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: July 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15797 Filed 7–10–08; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
17:19 Jul 10, 2008
Jkt 214001
Food and Drug Administration
[Docket No. FDA–2008–D–0137] (formerly
Docket No. 2000D–1383)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Surveillance and Detention Without
Physical Examination of Condoms.’’
This guidance document provides
information to FDA staff and industry
about FDA’s strategy for addressing
further imports of condoms from
manufacturers/shippers whose condoms
have failed to meet FDA’s minimum
acceptable quality criteria. The guidance
and the strategy are intended to help
assure that condoms imported to the
United States do not have defects that
could compromise their effectiveness
and present a health hazard to
consumers who rely on condoms for
protection from sexually transmitted
diseases as well as for contraception.
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
entitled ‘‘Surveillance and Detention
Without Physical Examination of
Condoms’’ 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 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 https://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: J.
Michael Kuchinski, Center for Devices
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
39969
and Radiological Health (HFZ–332),
Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 240–
276–0115.
SUPPLEMENTARY INFORMATION:
I. Background
Consumers use condoms as a barrier
to reduce the risk of catching or
spreading sexually transmitted diseases
and to reduce the risk of unintended
pregnancy. Defective condoms present a
potentially significant hazard to health
for these users.
FDA’s Center for Devices and
Radiological Health (CDRH) is aware
that some foreign manufacturers and
shippers of condoms repeatedly attempt
to import condoms that fail water leak
testing, indicating a level of defects that
does not satisfy the acceptable quality
criteria described in Compliance Policy
Guide 7124.21. To address the issue of
firms that repeatedly offer
nonconforming condoms for import to
the United States, FDA has devised a
risk-based tiered process for placing
condoms from identified manufacturers/
shippers on an import alert, for
releasing individual shipments, and for
removing condoms from identified
manufacturers/shippers from the import
alert and consequent potential detention
without physical examination. The
process involves three levels of import
surveillance and detention that may be
applied over a 24-month import
surveillance cycle.
This final guidance document
supersedes the draft guidance entitled
‘‘Surveillance and Detention Without
Physical Examination of Condoms,’’
which was announced in the Federal
Register on August 14, 2000 (65 FR
49585). The comment period closed on
November 13, 2000.
We received a small number of
comments, and FDA has made some
changes to the final guidance document
based on these comments. One
comment indicated that the risk of
detention is greater for high-volume
manufacturers because they have many
shipments and many FDA analyses in a
24-month period and, therefore, a
greater cumulative risk of Type 1
statistical sampling error resulting in
some shipments failing analyses even
though the shipments are acceptable.
After analyzing the import data, FDA
agrees that, in theory, such sampling
errors are possible, although FDA
believes that such errors are unlikely to
affect most condom manufacturers
because they appear to be producing
condoms at a defect rate well below the
acceptance criteria of the FDA test.
Nevertheless, the revised document
recognizes the opportunity for
E:\FR\FM\11JYN1.SGM
11JYN1
]]>Agencies
[Federal Register Volume 73, Number 134 (Friday, July 11, 2008)]
[Notices]
[Pages 39968-39969]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15797]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0372]
Global Harmonization Task Force, Study Groups 1 and 5; 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 final and proposed documents that have been prepared by
Study Groups 1 and 5 of the Global Harmonization Task Force (GHTF),
respectively. 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 FDA's current regulatory requirements;
elements of these documents may not be consistent with current U.S.
regulatory requirements. In particular, FDA seeks comments on the
advantages and disadvantages of the approaches in the GHTF documents,
particularly where they are not consistent with current practices for
the manufacture of products in the United States.
DATES: Submit written or electronic comments on these documents by
October 9, 2008. After October 9, 2008, 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 these
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 240-276-3151. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the documents.
Submit written comments concerning these documents to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.reguations.gov. 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 P. Lerner, GHTF,
Study Group 5, Office of Device Evaluation, Center for Devices and
Radiological Health (HFZ-470), 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 GHTF to facilitate
harmonization. Subsequent meetings have been held 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 relates to 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 guidelines that could help
lead to harmonization. As a result of its efforts, this group has
developed final document SG1/N44:2008. SG1/N44:2008 (final document)
entitled ``Role of Standards'' provides information on the use of
standards by a manufacturer when designing a medical device and,
subsequently, when demonstrating that the device conforms to relevant
essential safety and performance criteria.
Study Group 5 was initially tasked with the responsibility of
developing 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
proposed document SG5(PD)/N37:2007. The proposed document SG5(PD)/
N37:2007 entitled ``Clinical Investigations'' introduces general
principles of clinical investigations of medical devices and general
principles when considering the need for a clinical investigation of a
medical device. This document primarily addresses the use of clinical
investigations to support a marketing authorization application.
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. In particular, FDA seeks comments
on the
[[Page 39969]]
advantages and disadvantages of the approaches in the GHTF documents,
particularly where they are not consistent with current practices for
the manufacture of products in the United States.
III. Electronic Access
Persons interested in obtaining a copy of these documents 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 https://
www.ghtf.org. The CDRH Web site may be accessed at https://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. 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 Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: July 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15797 Filed 7-10-08; 8:45 am]
BILLING CODE 4160-01-S
