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Medical Devices / Regulatory Affairs

FDA Flags Unauthorized Devices for Diabetes Management

May 30, 2019
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The FDA warned that some manufacturers have been marketing illegal diabetes management devices, including automated insulin dosing systems and insulin pumps. Components used with other devices, such as continuous glucose monitors, have also been unlawfully marketed, the agency said.

The products haven’t been evaluated by the FDA for safety and effectiveness and can potentially pose serious risks to diabetic patients, such as inaccurate glucose level readings or unsafe insulin dosing.

Using unapproved or unauthorized devices for managing diabetes could lead to serious injury or death as their safety and effectiveness hasn’t been confirmed by the FDA, the agency said.

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