May 20, 2019

FDA issues warning on use of unauthorized devices for diabetes management

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration (FDA) on May 17 issued a warning to patients and healthcare professionals on the risks associated with the use of unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps, and automated insulin dosing systems.

The use of these devices could result in inaccurate blood glucose measurements or unsafe insulin dosing, putting the patient at risk for serious injury or death.

The FDA is aware of manufacturers illegally marketing unauthorized devices, which have not been reviewed by the agency for safety and effectiveness. The FDA is also aware of patients combining devices or components that are not intended for use with other devices.

The FDA says it is committed to streamlining regulatory pathways to promote innovation and patient access to these types of devices.

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