FDA issues 2 revised draft guidances for blood glucose meters

The FDA issued two revised draft guidances today for blood glucose monitors in home and health care settings, following a request from stakeholders for more clarification on design considerations and recommended standards for meters, according to a press release from the agency.

The new draft guidances are 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, according to the agency. The two draft guidances provide recommendations to industry about the types of information to be included in their premarket submissions for these devices.

“For the millions of Americans with diabetes, monitoring blood glucose levels is a part of daily life,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “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.”

In the statement, Gottlieb noted that there are “important differences” between blood glucose monitors used for patient management in the home vs. health care settings.

“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,” Gottlieb said. “On the other hand, patients in critical care settings may have physiological variables (eg, 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.”

The FDA is seeking comments on the revised draft guidances. These revisions do not change the recommended studies, the performance goals or the pathway to obtaining a Clinical Laboratory Improvement Amendments waiver for these devices.

Once finalized, the guidances will replace the final guidances issued in October 2016.

As Endocrine Today previously reported, a recent series of tests suggested that only six of 18 blood glucose monitoring systems that have been cleared by the FDA consistently delivered levels of accuracy based on international and U.S. regulatory standards, according to findings published in Diabetes Care.

In the study, the six top-performing blood glucose monitors based on the accuracy standard also met the four additional metrics, whereas the 12 lower-ranking blood glucose monitors demonstrated a wide array of overall performance with an overall compliant proportion ranging from 71% to 92%.

The researchers concluded that, in some cases, blood glucose monitors may result in treatment errors when patients depend on accurate results to determine treatment. – by Regina Schaffer

References:

FDA. Blood glucose monitoring test systems for prescription point-of-care use. Available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM626743.pdf. Accessed Nov. 29, 2018.

FDA. Self-monitoring blood glucose test systems for over-the-counter use. Available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM626742.pdf. Accessed Nov. 29, 2018.