FDA Guidance on Blood Glucose Monitors

Published: 12/03/2018

  • Food and Drug Administration
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

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