March 2014 Clinical Laboratory News: Volume 40, Number 3
FDA to Address Concerns About New Glucose Meter Regulations
AACC Webinar March 19
In the live AACC webinar, “New Blood Glucose Meter Guidance Unveiled: A Discussion With the FDA,” the director of FDA’s Division of Chemistry and Toxicology Devices, Courtney Lias, PhD, will answer questions about the recently released draft guidance documents that establish new premarket submission requirements for blood glucose monitors.
Currently, the agency only uses one set of criteria to evaluate the performance of blood glucose monitors, regardless of whether they are designed for use in professional healthcare settings or at home. This draft guidance now seeks to improve patient care by defining separate submission requirements for the two kinds of glucose meters. If implemented, these changes could have a significant impact on device manufacturers by increasing the submission requirements for point-of-care blood glucose monitors. Additionally, hospitals, long-term care facilities, and other healthcare providers that use these monitors would need to comply with more stringent personnel and quality control standards.
In light of these potential consequences, this draft guidance has raised important questions in the lab community about how it may affect point-of-care glucose programs. This webinar aims to answer these questions, while also explaining how blood glucose meters are currently regulated and helping laboratorians to understand the new professional use requirements.
To register, visit http://www.aacc.org/events/meetings/Pages/9079.aspx.
New Blood Glucose Meter Guidance Unveiled: A Discussion With the FDA
Wednesday, March 19