[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]
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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.
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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]
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