Document ID: FDA-2011-D-0464-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Staff; Availability: Content of Investigational Device Exemption and Premarket Approval Applications for Low Glucose Suspend Device Systems
Posted Date: 2011-06-22T04:00Z

[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36542-36543]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance document entitled ``Draft Guidance 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 This draft 
guidance document provides industry and Agency staff with 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 This draft guidance is not final 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 20, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance for Industry and Food and 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 301-847-8149. 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

[[Page 36543]]

Approval (PMA) Applications for Low Glucose Suspend (LGS) Device 
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 
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]
BILLING CODE 4160-01-P