[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Notices]
[Pages 30016-30017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12180]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0377]
Clinical Study Design and Performance of Hospital Glucose Sensors
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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The Food and Drug Administration (FDA) is announcing the following
public meeting entitled ``Clinical Study Design and Performance of
Hospital Glucose Sensors.'' The purpose of this public meeting is to
discuss clinical study design considerations and performance metrics
for innovative glucose sensors intended to be used in hospital point of
care settings.
DATES: Date and Time: The public meeting will be held on June 25, 2012,
from 8 a.m. to 5 p.m.
Location: The meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31, the Great Room (rm. 1503),
Silver Spring, MD 20993. Entrance for the public meeting participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The
public meeting will also be available to be viewed online via webcast.
Contact: Vicki Moyer, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5626, Silver Spring, MD 20993, 301-796-6148, FAX: 301-847-8513, email:
[email protected].
Registration: Registration is free and on a first-come, first-
served basis. Persons interested in attending this meeting must
register online by 4 p.m., June 15, 2012. Early registration is
recommended because facilities are limited and, therefore, FDA may
limit the number of participants from each organization. If time and
space permits, onsite registration on the day of the meeting will be
provided beginning at 7 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321,
Silver Spring, MD 20993, 301-796-5661, email:
[email protected], no later than June 15, 2012.
To register for the public meeting, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public meeting from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Those without
Internet access should contact Susan Monahan to register (see
Registration section of this document). Registrants will receive
confirmation after they have been accepted. You will be notified if you
are on a waiting list.
Streaming Web cast of the Public Meeting: This public meeting will
also be Web cast. Persons interested in viewing the Web cast must
register online by 4 p.m., June 15, 2012. Early registration is
recommended because Web cast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Web cast participants will be sent technical
system requirements after registration and will be sent connection
access information after June 20, 2012. If you have never attended a
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
Requests for Oral Presentations: This public meeting includes a
public comment session. During online registration you may indicate if
you wish to speak and the proposed title for the public comment
session, and which topics you wish to address. FDA has included general
topics in this document. FDA will do its best to accommodate requests
to make public comment. Following the close of registration, FDA will
determine the amount of time allotted to each speaker and will select
and notify participants by June 19, 2012. No commercial or promotional
material will be permitted to be presented or distributed at the
meeting.
Comments: FDA is holding this public meeting to obtain information
on innovative kinds of hospital glucose sensors. In order to permit the
widest possible opportunity to obtain public comment, FDA is soliciting
electronic or written comments on all aspects of the meeting topics.
The deadline for submitting comments related to this public meeting is
July 23, 2012.
Regardless of attendance at the public meeting, interested persons
may submit either electronic or written comments. Submit electronic
comments 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. It is only necessary
to send one set of comments. Please identify comments with the docket
number found in brackets in the heading of this document. In addition,
when responding to specific questions as outlined in section II of this
document, please identify the question you are addressing. 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.
[[Page 30017]]
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 (see Comments). 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 the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the meeting on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this meeting from the posted events list.).
SUPPLEMENTARY INFORMATION:
I. Background
FDA is seeking input from the clinical community, academia,
Government, industry, clinical laboratories, and other stakeholders
regarding clinical validation studies and performance criteria for
hospital glucose sensors. These types of devices are intended to be
used at the patient bedside, and are different from currently available
glucose sensors in that they are generally indwelling or inserted.
Furthermore, they are often designed to collect continuous or near-
continuous glucose concentrations for each patient.
These devices have the potential to benefit patient care but to
date they are not widely available. This is due, in part, to the
challenges in designing and studying these complex devices. One
challenge is the study design itself; determining the types of patients
to include and what data are needed to adequately validate performance
is often difficult given the varied hospital environment and patient
populations. Once the study is complete, determining whether or not the
results are sufficiently accurate and reliable for the proposed
intended use(s) is equally challenging.
The purpose of this public meeting is to share information about
the challenges in validating these kinds of hospital glucose sensors
and solicit public input and discussion. The feedback may increase
communication and collaboration within the stakeholder community, and,
ultimately, help overcome some of the current challenges associated
with designing clinical studies and generating clinical performance
data for these devices.
The public meeting will include two sessions of the following
topics: (1) The clinical studies and data needed to adequately validate
the performance of these devices in the intended use population and (2)
discussion of metrics that may be used to evaluate results to
demonstrate a safe and effective device. Each session will include
presentations from physicians, Government, and other experts in the
field. Presentations will be followed by panel discussions of session
topics and questions from the audience.
II. Topics for Discussion at the Public Meeting
The following questions represent the kinds of topics that will be
discussed at the meeting. The final questions to be discussed at each
session will be available the day of the meeting.
1. Who is the likely intended use population for these devices and
how will they be used in patient management? For example, will they be
used for general hospital, surgical, critically ill, pediatric
patients, etc.? What are the study considerations for evaluating the
devices in these different populations?
2. How does the intended use of the device affect the design of the
clinical studies and the evaluation and adequacy of device performance?
For example, are the accuracy needs for a device used to monitor trends
over time different from the accuracy needs of one where the individual
glucose results are used to replace discrete glucose measurements? Is
greater accuracy needed when the device is used in certain populations?
What metrics can be used to evaluate whether or not results from these
devices are sufficiently accurate and reliable for the proposed
intended use(s)?
3. What conditions, medications, or therapies have the potential to
cause interference and require evaluation? What kinds of studies/models
are appropriate to evaluate interference?
4. Differences in glucose concentrations may be observed when
testing arterial and venous blood samples from the same patient. How
can the potential differences in blood glucose concentrations be
addressed when conducting the clinical studies?
Dated: May 15, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-12180 Filed 5-18-12; 8:45 am]
BILLING CODE 4160-01-P