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FDA Division Director to Discuss Proposed Regulations That Aim to Improve Diabetes Patient Care

March 18, 2014

WASHINGTON, March 18, 2014 /PRNewswire-USNewswire/ — On March 19, AACC will host a webinar with FDA division director Courtney Lias, PhD, about FDA’s new draft guidance proposing separate performance and accuracy criteria for over-the-counter blood glucose meters used in the home and prescription point-of-care blood glucose meters used in the hospital.

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    WHO:                  Dr. Lias is director of
                          the Division of Chemistry
                          and Toxicology Devices in
                          the Office of In Vitro
                          Diagnostics at FDA's
                          Center for Devices and
                          Radiological Health, and
                          is a vocal proponent of
                          improving blood glucose
                          meter accuracy and
                          reliability.

    WHEN:                Wednesday, March 19

                         2:30-3:30 p.m.

    WHERE:                New Blood Glucose Meter
                          Guidance Unveiled: A
                          Discussion With the FDA

    WHY:                  Improved blood glucose
                          (sugar) testing gives
                          healthcare providers and
                          people with diabetes
                          better tools to manage
                          blood glucose levels.

Not all blood glucose meters are created equal. At-home blood glucose meters help many of the 19 million Americans with diabetes to manage their condition, and when people with diabetes are hospitalized, healthcare professionals measure blood glucose using so-called point-of-care meters to determine what medical treatment is needed. Blood glucose monitoring test systems used for patient management in the healthcare setting and for diabetes management in the home setting have different intended use populations with unique characteristics and device design requirements. For example, critically ill patients in healthcare settings may have physiological variables that could interfere with the accuracy of the blood glucose meter.

FDA’s new draft guidance aims to improve blood glucose meter safety and efficacy by recommending distinct performance parameters for at-home and point-of-care meters, which are currently evaluated using the same criteria. The agency believes this will ensure that these devices are better designed to meet the needs of their intended populations. If implemented, though, this guidance could also have far-reaching implications for device manufacturers, hospitals, long-term care facilities, and other healthcare providers who perform point-of-care glucose testing and who will have to comply with more stringent personnel and quality control standards. In this webinar, Dr. Lias will answer questions about how this guidance could impact the healthcare professionals directly involved in point-of-care glucose testing and how they can work with FDA to refine the guidance and improve diabetes patient care.

For the full draft guidance, see Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff.

About AACC
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.

Molly Polen
AACC
Director of Communications & PR
(p) 202.420.7612
(c) 703.598.0472
mpolen@aacc.org

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SOURCE AACC


Source: PR Newswire



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