The U.S. Food and Drug Administration (FDA) has issued an important safety communication regarding blood pressure measurement devices. This announcement, made on September 16, 2025, highlights the risks of using unauthorized devices that claim to measure or estimate blood pressure. Healthcare professionals, caregivers, and patients are urged to take note as the use of unapproved devices can lead to inaccurate readings and serious health consequences.
Why is this warning necessary?
Many blood pressure monitors sold over-the-counter (OTC) lack FDA authorization. This means their safety and effectiveness in providing accurate results have not been evaluated. The consequences of relying on such unauthorized devices can be severe. Inaccurate blood pressure readings may lead to errors in diagnosing or managing hypertension or hypotension, conditions that often show no physical symptoms. Timely and correct measurements are essential to avoiding complications such as stroke, heart attack, kidney failure, or cognitive decline.
What are the risks of unauthorized blood pressure devices?
Blood pressure monitors, including wearables like smartwatches or smart rings that claim to provide readings, are subject to FDA standards to ensure their safe use in medical care. Unauthorized devices introduce several risks:
- Failure to detect critical changes in blood pressure levels.
- Delays in seeking medical treatment due to reliance on faulty measurements.
- False alerts prompting unwarranted medical interventions.
- Improper medication adjustments based on inaccurate readings.
These risks underscore the need to use FDA-authorized blood pressure devices, especially for individuals managing chronic conditions.
How can you identify FDA-authorized devices?
To ensure your blood pressure device is authorized, search the FDA’s 510(k) database using the device name. Authorized devices typically carry the product code DXN. Avoid buying devices from online marketplaces or direct sellers whose products have not been evaluated by the FDA.
If you are unsure whether a specific device meets regulatory standards, consult your healthcare provider for guidance. They can help select an FDA-authorized device appropriate for your needs.
What actions is the FDA taking?
The FDA has increased its monitoring of devices that claim to measure blood pressure and is actively addressing the presence of unauthorized products in the market. These actions include scrutinizing software features in wearables like smartwatches and smart rings that advertise unapproved blood pressure tracking. The Agency has committed to fostering innovation while keeping patient safety front and center.
To help improve oversight, the FDA encourages consumers and healthcare providers to report problems associated with unauthorized devices. Reports can be submitted through the FDA’s MedWatch Voluntary Reporting Form. Healthcare personnel in regulated facilities should follow their respective procedures for mandatory reporting.
What should you do next?
If your medical care depends on accurate blood pressure monitoring, take these steps:
- Stop using any device that has not been authorized by the FDA.
- Verify the authorization status of your device using the FDA’s 510(k) database.
- Report concerns or adverse events related to unauthorized devices through proper channels.
- Seek advice from a healthcare provider about selecting a safe and reliable monitor.
Conclusion
The FDA’s warning about unauthorized blood pressure devices aims to prevent serious health risks stemming from inaccurate measurements. Healthcare teams and consumers must prioritize FDA-authorized devices to ensure patient safety and effective treatment. Regular updates from the FDA should be monitored for any new developments.
Disclaimer
This content is for informational purposes only and does not constitute legal or clinical advice. Always consult appropriate professionals when addressing regulatory or medical device concerns.
Mandatory FDA Notice
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/safety-communications/do-not-use-unauthorized-devices-measuring-blood-pressure-fda-safety-communication