FDA Guidance on Blood Glucose Monitors

PUBLISHED: Dec 3, 2018
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has issued two revised draft guidances regarding the use of point-of-care blood glucose monitors in health care and home settings. The new draft guidances are:

When finalized, these draft guidances will update guidances last issued in 2016 and will:

  • Provide more clarification on design considerations and recommended standards for point-of-care blood glucose monitors.
  • Address the differences in use and consideration for over-the-counter glucose meters and test strips for use in the home where users vary in age, dexterity, vision, training on how to use blood glucose tests, and other factors critical to the accurate use of the device and patients in critical care settings who may have physiological variables (e.g., abnormal oxygen levels, medications) that could interfere with the accuracy of the blood glucose meter.

According to the FDA, these two updated draft guidances will 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, follow the link below for comment submission instruction. StayAlert! is monitoring this topic and will publish another notice when these guidanes are finalize.

Included with today’s notice are example policies related to point-of-care blood glucose monitoring in the acute care and home health setting.

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