FDA Warns Against Use of Unauthorized Diabetes Devices – Medscape

The US Food and Drug Administration (FDA) has issued a warning against the use of unauthorized diabetes devices, including insulin pumps and continuous glucose monitors (CGMs), as well as other nonapproved devices and algorithms used to create systems for automated insulin delivery.  “These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death,” according to the FDA statement. The ...

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