[Federal Register Volume 76, Number 234 (Tuesday, December 6, 2011)]
[Notices]
[Pages 76166-76167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31214]


-----------------------------------------------------------------------

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Draft Guidance for Industry and Food and Drug Administration 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 Artificial Pancreas Device Systems; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance document entitled ``Draft Guidance 
for Industry and FDA Staff: The Content of Investigational Device 
Exemption (IDE) and Premarket Approval (PMA) Applications for 
Artificial Pancreas Device Systems.'' This draft guidance document 
provides industry and the Agency staff with guidelines for developing 
premarket submissions for artificial pancreas device systems, in 
particular, the Control-to-Range (CTR) and Control-to-Target (CTT) 
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 This draft guidance is not final nor is it in effect at 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draft guidance before it begins work on the

[[Page 76167]]

final version of the guidance, submit either electronic or written 
comments on the draft guidance by March 5, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance for Industry and FDA Staff: 
The Content of Investigational Device Exemption (IDE) and Premarket 
Approval (PMA) Applications for Artificial Pancreas 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Phil Desjardins, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002, (301) 
796-5678.

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 (CGM) via control algorithm. There are a variety of types of 
artificial pancreas systems depending upon the nature of the control 
algorithm, including CTR, CTT, and Low Glucose Suspend systems. On June 
22, 2011 (76 FR 36542), FDA announced the availability of the draft 
guidance document entitled ``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.'' In this notice, FDA is announcing a draft guidance 
document with recommendations developing premarket applications for 
other types of artificial pancreas systems.
    CTR and CTT systems link a continuous glucose monitor to an insulin 
pump and automatically reduce or increase insulin infusion based upon 
specified thresholds of measured interstitial glucose levels. These 
types of systems are designed to aid in the management of diabetes. 
There are significant challenges in creating an autonomous system, 
which were discussed in a joint FDA and NIH (National Institutes of 
Health) 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 device. This workshop sought feedback on 
ways to overcome the obstacles toward 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 guidances for artificial pancreas device systems. 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.

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 developing 
investigations of and premarket applications for Artificial Pancreas 
Device systems, particularly the CTT and CTR 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 FDA Staff: The Content of 
Investigational Device Exemption (IDE) and Premarket Approval (PMA) 
Applications for Artificial Pancreas Device Systems,'' you may either 
send an email request to [email protected] 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 1786 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 
collection 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 56.11 
are approved under OMB control number 0910-0130; the collections of 
information in 21 CFR parts 801 and 809 are approved under OMB control 
number 0910-0485, the collections of information in 21 CFR part 812 are 
approved under OMB control number 0910-0078, and the collections of 
information in 21 CFR part 814 are approved under OMB control number 
0910-0231; the collections of information in 21 CFR part 820 are 
approved under OMB control number 0910-0073.

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: November 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31214 Filed 12-5-11; 8:45 am]
BILLING CODE 4160-01-P