[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36542-36543]
[FR Doc No: 2011-15541]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0464]

Draft Guidance for Industry and Food and Drug Administration
Staff: The Content of Investigational Device Exemption and Premarket
Approval Applications for Low Glucose Suspend Device 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availability of the draft guidance document entitled ``Draft Guidance
for Industry and Food and Drug Administration Staff: The Content of
Investigational Device Exemption (IDE) and Premarket Approval (PMA)
Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft
guidance document provides industry and Agency staff with
recommendations that are intended to improve the safety and
effectiveness of LGS Device Systems. This draft guidance is not final
nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 20, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and Food and
Drug Administration Staff: The Content of Investigational Device
Exemption (IDE) and Premarket Approval (PMA) Applications for Low
Glucose Suspend (LGS) Device Systems'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Charles Zimliki, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 2556, Silver Spring, MD 20993-0002, 301-
796-6297.

SUPPLEMENTARY INFORMATION:

I. Background

    Diabetes mellitus has reached epidemic proportions in the United
States and more recently, worldwide. The morbidity and mortality
associated with diabetes is anticipated to account for a substantial
proportion of health care expenditures. Although there are many devices
available that help patients manage the disease, FDA recognizes the
need for new and improved devices for treatment of diabetes. One of the
more advanced diabetes management systems is an artificial pancreas
device system. An artificial pancreas system is a type of autonomous
system that adjusts insulin infusion based upon the continuous glucose
monitor via control algorithm. There are a variety of types of
artificial pancreas systems depending upon the nature of the control
algorithm. They can be generally divided into three categories, LGS,
Treat-to-Range, and Treat-to-Target. In this notice, FDA is announcing
a draft guidance for the first type of artificial pancreas, the LGS
system. An LGS system links a continuous glucose monitor to an insulin
pump and automatically reduces or suspends insulin infusion temporarily
based upon specified thresholds of measured glucose levels. This type
of system is designed to reduce or mitigate the likelihood of a
hypoglycemic event. There are significant challenges in creating an
autonomous system, which were discussed in a joint FDA and National
Institutes of Health (NIH) artificial pancreas workshop on November 10,
2010 (information available at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm226251.htm. Currently, there is no
FDA-approved artificial pancreas for home use. This workshop sought
feedback on ways to overcome the obstacles towards developing an
artificial pancreas. The feedback received from this workshop and the
continued communication with investigators in this field has provided
valuable input for FDA's first guidance for a LGS device. This guidance
will outline considerations for development of clinical studies, and
recommends elements that should be included in IDE and PMA
applications, focusing on critical elements of safety and effectiveness
for approval of this device type. The guidance includes one suggested
approach to support safety and effectiveness, but given the early stage
of this technology, FDA is open to considering alternative study design
approaches and seeks comments regarding alternative approaches. FDA
particularly seeks comments regarding the validity of the Continuous
Glucose Monitor based event for hypoglycemia endpoint, pivotal study
design, and patient population. As the LGS system is one of three types
of artificial pancreas systems, comments to the LGS guidance will not
only assist FDA in finalizing guidance on LGS systems, but also assist
in developing future draft guidance for the other types of artificial
pancreas systems. FDA continues to work with the investigators in this
field and is developing a second guidance to address the remaining
artificial pancreas device systems.

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 LGS Device
systems. 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. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Draft Guidance for Industry and Food and Drug Administration Staff:
The Content of Investigational Device Exemption (IDE) and Premarket

Approval (PMA) Applications for Low Glucose Suspend (LGS) Device
Systems,'' you may either send an e-mail request to<EMAIL_ADDRESS>to receive an electronic copy of the document or send a fax request to
301-847-8149 to receive a hard copy. Please use the document number
1748 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of
information found in FDA regulations and guidance documents. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR parts
801 and 809 are currently approved under OMB control number 0910-0485,
the collections of information in 21 CFR part 812 are currently
approved under OMB control number 0910-0078, and the collections of
information in 21 CFR part 814 are currently approved under OMB control
number 0910-0231.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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: June 16, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-15541 Filed 6-21-11; 8:45 am]
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