[Federal Register Volume 71, Number 205 (Tuesday, October 24, 2006)]
[Notices]
[Pages 62271-62272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17757]


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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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Draft Guidance for 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 This draft guidance provides FDA's 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DATES: Submit written or electronic comments on this draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance for Industry and FDA Staff; 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    Submit written comments concerning this draft guidance to the 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://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 This draft guidance document provides the FDA's 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 
[email protected] 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://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at 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