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Do Not Use Unauthorized Devices for Measuring Blood Pressure: FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using unauthorized devices that claim to measure or estimate blood pressure. Many blood pressure devices currently sold over-the-counter (OTC) do not have FDA marketing authorization, meaning the FDA has not evaluated the safety and effectiveness of those devices. The FDA recommends looking for an FDA-authorized device appropriate for your needs.

This safety communication provides:

• Recommendations for consumers, patients, caregivers, and health care providers.
• Background on the safety concerns and the FDA’s actions in this area. 
• Instructions for reporting problems with blood pressure devices to the FDA.  

Questions?

If you have questions, contact the Division of Industry and Consumer Education.