[Federal Register Volume 75, Number 10 (Friday, January 15, 2010)]
[Notices]
[Pages 2549-2550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-742]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0604]
Clinical Accuracy Requirements for Point of Care Blood Glucose
Meters; Public Meeting; Request for Comments
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 a public
meeting entitled: Clinical Accuracy Requirements for Point of Care
Blood Glucose Meters. The purpose of the public meeting is to discuss
the clinical accuracy requirements of blood glucose meters and other
topics related to their use in point of care settings.
Dates and Times: The public meeting will be held on March 16, 2010,
from 9 a.m. to 5 p.m. and on March 17, 2010, from 9 a.m. to 3:40 p.m.
Location: The public meeting will be held at the Hilton Hotel in
Gaithersburg, MD, 620 Perry Pkwy., Gaithersburg, MD 20877. For
directions, please refer to the meeting Web page at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm187406.htm.
Contact Person: Arleen Pinkos, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 5618, Silver Spring, MD 20993, 301-
796-6152, FAX: 301-847-8573, e-mail: [email protected].
Registration: Persons interested in attending the meeting must
register by February 15, 2010. If you wish to attend this public
meeting, you must register
[[Page 2550]]
online at http://www.fda.gov/MedicalDevices/NewsEvents/MeetingsConferences/ucm187406.htm by close of business on February 15,
2010. Those without Internet access may register by contacting
Christine Kellerman at 301-796-5711. When registering, you must provide
your name, title, company or organization (if applicable), address,
phone number, and e-mail address. There is no fee to register for the
public meeting and registration will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
Registration on the day of the public meeting will be permitted on a
space-available basis beginning at 8:45 a.m.
If you need special accommodations due to a disability, please
contact the hotel at 301-977-8900 at least 7 days prior to the meeting.
Directions to the hotel and other information about the meeting may
be found at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm187406.htm.
Comments: FDA is holding this public meeting to raise public
awareness about the accuracy and clinical use of blood glucose meters,
to share ideas on the challenges associated with their use, to seek
public comments on this topic and to work towards identifying
solutions. The deadline for submitting comments regarding this public
meeting is April 20, 2010, by 5 p.m. EST.
Regardless of attendance at the meeting, interested persons may
submit written or electronic comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Submit a single copy of electronic comments or two
paper copies of any mailed comments, except that individuals may submit
one paper copy. Comments are to be identified 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.
SUPPLEMENTARY INFORMATION: The workshop will include 3 sessions on the
following: (1) Clinical accuracy for blood glucose meters, (2) tight
glycemic control in clinical settings, and (3) medications and other
substances that interfere with the technologies the devices employ.
Each session will include presentations from physicians, laboratories,
government and industry representatives, and patient advocates who are
experts in each area. Presentations will be followed by panel
discussions of session topics and questions from the audience.
Glucose meters are used by millions of people with diabetes every
day. These devices have become smaller, faster, and more accurate over
the past 3 decades and now allow for better glycemic control by
diabetics than in the past. Glucose meters are not only used by
diabetics at home, they are also used by health care providers in a
variety of settings such as hospitals, emergency response units,
nursing homes, and physicians' offices.
Some in the clinical and patient communities have questioned
whether the current FDA-recognized accuracy standards for blood glucose
meters are acceptable and have challenged FDA to require tighter
performance standards. Blood glucose meters are being used in clinical
settings and at home in ways that are not within the intended use of
the devices as evaluated by FDA. For example, glucose meters are
increasingly being used to achieve tight glycemic control despite the
fact that these devices have not been cleared for this use. There is
currently no consensus that blood glucose meters currently on the
market are accurate enough to be used in this way. Still, other
stakeholders believe the current analytical performance of glucose
meters is adequate and that there is no evidence to support the need
for higher standards. Other factors affecting the performance of blood
glucose meters include administered drugs, common physiological
conditions (such as diabetic ketoacidosis), and user-interface issues.
For example, the administration of therapies containing maltose, which
are commonly prescribed to patients in the hospital, have resulted in
falsely elevated glucose results. (FDA issued a Public Health
Notification about this risk. See http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm and
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm177189.htm for more information.)
In response to the issues identified previously, FDA is
reconsidering the current FDA-recognized glucose meter accuracy
standards, and is considering whether FDA review criteria for these
devices should be changed for reasons of public health. FDA is
interested in hearing from clinical experts about the clinical
requirements for blood glucose meter accuracy and precision, and the
benefits and risks of using glucose meters to achieve and maintain
tight glycemic control. The appropriate analytical and clinical
accuracy requirements for blood glucose meters will be discussed during
this meeting, as well as the potential benefits and challenges of
meeting those requirements. We are seeking participation from all
stakeholders including, but not limited to: Physicians, nurses, health
care providers who work in intensive care settings, industry, diabetes
educators, professional societies, consumers, and patient advocate
groups.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm187406.htm.
Dated: January 8, 2010.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. 2010-742 Filed 1-14-10; 8:45 am]
BILLING CODE 4160-01-S