[Federal Register: October 24, 2006 (Volume 71, Number 205)]
[Notices]
[Page 62271-62272]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc06-59]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0353]
Draft Guidance for Industry and Food and Drug Administration
Staff; Total Product Life Cycle for Portable Invasive Blood Glucose
Monitoring Systems; 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availability of the draft guidance entitled ``Draft Guidance for
Industry and FDA Staff: Total Product Life Cycle for Portable Invasive
Blood Glucose Monitoring Systems.'' This draft guidance provides FDA's
recommendations concerning portable invasive blood glucose monitoring
systems (BGMSs).
DATES: Submit written or electronic comments on this draft guidance by
January 22, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and FDA Staff;
Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring
Systems '' 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Submit written comments concerning this draft guidance to the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: Carol Benson, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Road, Rockville, MD 20850, 240-276-0490 x117.
SUPPLEMENTARY INFORMATION:
I. Background
Portable invasive BGMS devices were introduced in the late 1970s
and are considered one of the most important medical advances in
diabetes care. This draft guidance document provides the FDA's
recommendations concerning BGMS devices. In addition to recommendations
for preparation of premarket notifications (510(k)), the draft guidance
document discusses features of device design and risk management,
including those relating to human factors. The draft guidance document,
when finalized, is intended to complement International Standards
Organization standards on risk management for medical devices and
BGMSs. The scope of this draft guidance document includes BGMS devices,
used in the quantitative measurement of glucose in blood by lay users
at home or by professionals in hospitals and other point of care
settings, to manage carbohydrate metabolism disorders including
diabetes mellitus. When this guidance document is finalized, FDA
expects that this guidance document will enable FDA to make more
efficient and better-informed decisions based on more consistent data,
and better contribute to the marketing of more
[[Page 62272]]
reliable, reproducible, and simple-to-use commercial devices.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the total
product life cycle for portable invasive BGMSs. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Draft Guidance for Industry and
FDA Staff; Total Product Life Cycle for Portable Invasive Blood Glucose
Monitoring Systems,'' you may either send an e-mail request to
dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 240-276-3151 to receive a hard copy. Please use
the document number 1603 to identify the guidance you are requesting.
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. 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.
A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets
.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 USC 3501-3520). The
collections of information in 21 CFR part 807 have been approved under
OMB control number 0910-0120, the collections of information in 21 CFR
part 820 have been approved under OMB control number 0910-0073, and the
collections of information in 21 CFR part 801 have been approved under
OMB control number 0910-0485.
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 submit 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.
Dated: October 11, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-17757 Filed 10-23-06; 8:45 am]
BILLING CODE 4160-01-S