FDA Division Director to Discuss Proposed Regulations That Aim to Improve Diabetes Patient Care
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— On March 19, AACC will host a webinar with FDA division director Courtney Lias, PhD, about FDA’s new draft guidance proposing separate performance and accuracy criteria for over-the-counter blood glucose meters used in the home and prescription point-of-care blood glucose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.
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FDA’s new draft guidance aims to improve blood glucose meter safety and efficacy by recommending distinct performance parameters for at-home and point-of-care meters, which are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.
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