Document ID: FDA-2009-N-0604-0001
Agency: fda
Document Type: Notice
Title: Clinical Accuracy Requirements for Point of Care Blood Glucose Meters; Public Meeting; Request for Comments
Posted Date: 2010-01-15T05:00Z

[Federal Register: January 15, 2010 (Volume 75, Number 10)]
[Notices]               
[Page 2549-2550]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja10-72]                         

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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: Arleen.Pinkos@fda.hhs.gov.
    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