[Federal Register Volume 75, Number 197 (Wednesday, October 13, 2010)]
[Notices]
[Pages 62844-62845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25600]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Innovations in Technology for the Treatment of Diabetes: Clinical
Development of the Artificial Pancreas (an Autonomous System); Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) and the National Institutes
of Health (NIH) are announcing a public workshop entitled ``Innovations
in Technology for the Treatment of Diabetes: Clinical Development of
the Artificial Pancreas (an Autonomous System).'' The topics to be
discussed are the current state of device systems for autonomous
systems for the treatment of diabetes mellitus, the challenges in
developing this expert system using existing technology, a discussion
of the clinical expectations and success criteria for these systems,
and a discussion of development plans for the transition of this device
system toward an outpatient setting.
Date and Time: The public workshop will be held on November 10,
2010, from 8 a.m. to 5 p.m. Persons interested in attending this
meeting must register by 5 p.m. on November 3, 2010.
Location: The meeting will be held at the Hilton Washington, DC
North/Gaithersburg Hotel, 620 Perry Pkwy., Gaithersburg, MD 20877.
Contact: Charles Zimliki, Food and Drug Administration, Center for
Devices and Radiological Health (CDRH), 10903 New Hampshire Ave., Bldg.
66, rm. 2556, Silver Spring, MD 20993-0002, 301-796-6297, Fax: 301-847-
8109, e-mail: [email protected].
Registration: Registration is free and will be on a first-come,
first-served basis. To register for the public workshop, webinar or
onsite attendance, please visit the following Web site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm226251.htm (select the appropriate meeting from the list). Please
provide complete contact information for each attendee, including name,
title, affiliation, address, e-mail, and telephone number. For those
without Internet access, please call Victoria Wagman at 301-796-6581 to
register. Registration requests should be received by 5 p.m. on
November 3, 2010. Early registration is recommended because seating is
limited and therefore FDA/NIH may limit the number of participants from
each organization. If time and space permits, onsite registration on
the day of the public meeting will be provided beginning at 7 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan (e-mail: [email protected]) at least 7
days in advance.
SUPPLEMENTARY INFORMATION:
I. Background
CDRH has undertaken an initiative to proactively facilitate medical
device innovation to address unmet public health needs. As part of this
initiative, CDRH with NIH have focused on the development of the
artificial pancreas (or Autonomous System) for the treatment of
diabetes mellitus. An artificial pancreas is a medical device that
links a glucose monitor to an insulin infusion pump where the pump
automatically takes action (using a control algorithm) based upon the
glucose monitor reading. As control algorithms can vary significantly,
there are a variety of artificial pancreas systems currently under
development. These systems can range from low glucose suspend, to
control-to-range, to control-to-target, to bihormonal control where
each device has different purposes or intended uses for controlling
blood sugars. In addition, most research in this area uses existing
medical device technology, which might limit the performance and
evaluation of these systems. Given these device limitations,
preliminary research has focused on evaluating these systems in
[[Page 62845]]
a hospital-based environment, where the risks to the patient are
minimized. CDRH and NIH seek feedback on ways to overcome obstacles in
the development of an artificial pancreas and what might be considered
reasonable clinical expectations for systems considering the available
existing technology.
This public workshop is to seek input from a wide range of
constituencies including but not be limited to industry, academia,
patient/consumer advocacy groups, professional organizations, and other
State and Federal bodies under aligned public health missions, to
address the issues outlined in this notice. During the public workshop,
there will be an open dialogue between Federal Government and experts
from the private and public sectors regarding the topics described in
this document. Workshop participants will not be expected to develop
consensus recommendations, but rather to provide their perspectives on
the clinical development of these device systems.
II. Issues for Discussion
The workshop will focus on three topics: (1) Technical
considerations when developing a clinical study design; (2)
expectations of the various artificial pancreas device systems; and (3)
a discussion of the various development plans for the Artificial
Pancreas System. The discussion of these general topics should not be
limited by current statutes or regulations and will include, but not be
limited to, discussion of the preceding questions.
III. Where can I find more information about this public workshop?
Background information on the public workshop, registration
information, the agenda, and other relevant information will be posted,
as it becomes available, on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm226251.htm.
IV. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, Rm. 6-30, Rockville, MD 20857.
Dated: October 5, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-25600 Filed 10-12-10; 8:45 am]
BILLING CODE 4160-01-P