[Federal Register Volume 77, Number 226 (Friday, November 23, 2012)]
[Notices]
[Pages 70168-70169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28339]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 guidance entitled ``The Content of Investigational 
Device Exemption (IDE) and Premarket Approval (PMA) Applications for 
Artificial Pancreas Device Systems.'' FDA is issuing this guidance to 
inform industry and Agency staff of its recommendations for analytical 
and clinical performance studies to support premarket submissions for 
artificial pancreas systems.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``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 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: Stayce Beck, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5609, Silver Spring, MD 20993, 301-796-6514.

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 a control algorithm. 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 (IDE) and Premarket 
Approval Applications (PMA) for Low Glucose Suspend (LGS) Device 
Systems.'' On December 6, 2011 (76 FR 76166), FDA announced the 
availability of the draft guidance document entitled ``The Content of 
Investigational Device Exemption (IDE) and Premarket Approval (PMA) 
Applications for Artificial Pancreas Device Systems.'' Ninety-seven 
sets of comments were received in total for both guidance documents. In 
response to comments, FDA made clarifying edits in several sections. 
Based on the similarities between the two draft guidance documents and 
the comments received, these two documents have been combined into one 
guidance document, which provides industry and Agency staff with 
recommendations for developing premarket submissions for artificial 
pancreas device systems (APDS) and is the subject of this Federal 
Register document. The guidance outlines considerations for development 
of clinical studies, and recommends elements that should be included in 
IDE and PMA applications for artificial pancreas systems, including 
threshold suspend systems (also known as low glucose suspend systems), 
single hormonal control systems, and bihormonal control systems. This 
guidance focuses on critical elements of safety and effectiveness for 
approval of this device type, while keeping in mind the risks diabetic 
patients face everyday.
    Artificial pancreas device systems are class III devices and 
require the submission of a PMA. All components of the APDS (insulin 
pump, continuous glucose monitoring system, blood glucose device, and 
control algorithm and signal processing functional component) are 
considered essential components of the system and will be regulated as 
class III devices when used as part of an APDS. As such, all 
information sufficient for approval of the components as part of the 
system should be provided in the PMA submission (e.g., manufacturing 
information, specifications, etc.).

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on the content of IDE and PMA applications 
for artificial pancreas 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 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 
the document ``The Content of Investigational Device Exemption (IDE) 
and Premarket Approval (PMA)

[[Page 70169]]

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 1759 to identify the guidance 
you are requesting.

IV. Paperwork Reduction Act

    This 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 54.4 
are approved under OMB control number 0910-0396; the collections of 
information in 21 CFR 56.115 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 either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: November 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28339 Filed 11-21-12; 8:45 am]
BILLING CODE 4160-01-P