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FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States

An FDA Safety Communication

Nathan Botts 0 58 Article rating: No rating

The U.S. Food and Drug Administration (FDA) is warning health care providers and people with diabetes of risks associated with use of devices for diabetes management unauthorized for sale in the U.S., whether used alone or along with other devices. 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.

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Health eProfile team members have been at the forefront of developing tools to engage a broad community of patients and people to successfully access, store and manage their personal health information.

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