The FDA issued two revised draft guidances today relating to over-the-counter and prescription blood glucose monitors.
The new documents, which are intended to update guidances issued in 2016, were based on feedback from stakeholders, who requested more clarification on design considerations and recommended standards, according to the U.S. regulatory agency.
The guidances include recommendations for the medtech industry about the kind of information that should be included premarket submission packages for blood glucose monitoring test systems.
FDA chief Dr. Scott Gottlieb noted that there are important distinctions to be made between point-of-care and over-the-counter blood glucose monitors. People who use over-the-counter glucose meters and strips are extremely diverse in age, vision, training and dexterity – all of which could impact the accurate use of blood glucose monitoring systems.
People in a healthcare setting could have physiological variables that could impact the accuracy of the systems, according to the FDA commissioner.
“For the millions of Americans with diabetes, monitoring blood glucose levels is a part of daily life. It’s critical that patients with diabetes have access to blood glucose monitors that are safe, accurate, and easy to use. That’s why the FDA has been modernizing our recommendations for the design and performance of these devices,” Gottlieb said in prepared remarks.
“We’re committed to improving the safety and performance of medical devices, and to taking new steps to help make sure that products continually incorporate new technology that can improve safety and better meet the needs of patients and providers,” he added. “The updated draft guidances issued today include recommendations to help ensure greater accuracy, reliability, and safe use of blood glucose monitoring test systems for each setting.”