November 29, 2018
“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,” said FDA Commissioner Scott Gottlieb, M.D. “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. Blood glucose monitors are used for patient management in both the home and the health care settings, and there are important differences in these technologies. Patients who use over-the-counter glucose meters and test strips in the home vary in age, dexterity, vision, training on how to use blood glucose tests, and other factors critical to the accurate use of the device. On the other hand, patients in critical care settings may have physiological variables (e.g., abnormal oxygen levels, medications) that could interfere with the accuracy of the blood glucose meter. 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.”
Today, the U.S. Food and Drug Administration issued two revised draft guidances regarding blood glucose monitors used in health care and home settings: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use and Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. These new draft guidances, when finalized, will update two final guidances issued in 2016. The changes are based on additional feedback from stakeholders requesting more clarification on design considerations and recommended standards. Today’s action is part of the FDA’s continuing efforts to improve the development of new blood glucose meters based on feedback from both patients and health care providers, especially on the usability of glucose monitors. The two draft guidances provide recommendations to industry about the types of information to be included in their premarket submissions for these devices.
The FDA is seeking comments on the revised draft guidances issued today. These revisions do not change the recommended studies, the performance goals, or the pathway to obtaining Clinical Laboratory Improvement Amendments waiver for these devices.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.