FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health
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.