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.
More information on the meeting can be found by visiting: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm187406.htm.
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.
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. 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. 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.
In light of these discussions, 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.
