On September 16, 2025, the US Food and Drug Administration (FDA) issued a safety communication warning consumers, patients, caregivers, and healthcare providers about risks related to unauthorized devices that claim to measure or estimate blood pressure. According to the alert, many blood pressure monitoring devices currently sold over the counter do not have FDA marketing authorization. This means the FDA has not evaluated their safety, accuracy, or effectiveness. The agency recommends using only FDA-authorized devices that meet established performance and safety standards.
Accurate blood pressure measurement is essential to diagnosing and managing hypertension or hypotension. Inaccurate readings can result in delayed or missed treatment, inappropriate medication adjustments, or unnecessary medical interventions. These errors increase the risk of serious health complications, including stroke, heart attack, heart failure, kidney failure, cognitive decline, and premature death. Because high blood pressure often presents without symptoms, reliable monitoring is a critical part of early intervention and ongoing care.
The FDA notes that some unauthorized devices are embedded in wearable technologies, such as smartwatches or smart rings, and may be marketed directly to consumers or sold through online marketplaces. The safety and effectiveness of these features have not been reviewed by the agency. Healthcare providers are advised to speak with patients about the potential dangers of using unapproved devices and to guide them in selecting an appropriate, FDA-authorized option when needed.
To confirm whether a blood pressure device is FDA-authorized, users can search the FDA’s 510(k) database using the product name. Authorized devices generally carry the product code DXN. Providers and caregivers should report any adverse events or device problems through the FDA’s MedWatch Voluntary Reporting Form, as timely reporting supports ongoing monitoring and patient safety.
The FDA stated it is taking steps to address the marketing of unauthorized devices and remains committed to balancing innovation in digital health with appropriate regulatory oversight.
You can access the FDA safety communication here.
Compliance Perspective
Issue
Facilities must ensure that any medical devices used for patient care meet regulatory requirements and have been properly evaluated for safety and effectiveness. The use of unauthorized or unverified devices can lead to inaccurate clinical data, resulting in delayed or inappropriate treatment, potential harm to residents or patients, and regulatory consequences. It is critical that healthcare providers confirm device authorization status and maintain clear procurement and usage policies aligned with FDA guidance.
Discussion Points
- Review policies and procedures related to medical device procurement, usage, and verification. Ensure staff are trained to confirm that devices in use—particularly those involved in diagnostic functions—are FDA-authorized for their intended purpose. Consider working with a consultant to assess current device management protocols, identify any use of unauthorized products, and strengthen procedures to reduce clinical and regulatory risk.
- Educate staff on the risks associated with unauthorized medical devices, including wearables that claim to provide diagnostic data such as blood pressure readings. Emphasize the importance of using only FDA-authorized equipment in clinical decision-making. Med-Net Academy offers the course Assessing Arterial Blood Pressure, which covers essential techniques for accurate blood pressure measurement using both manual and automated methods. The course also includes guidance on positioning, equipment use, interpreting readings, and obtaining orthostatic hypotension measurements.
- Conduct regular audits of devices currently in use or available to patients, particularly those introduced through non-traditional channels (e.g., online orders, direct-to-consumer purchases). Consultants can support facilities in developing or enhancing internal monitoring tools and audit processes to ensure only authorized, compliant devices are used, and that staff know how to respond if unauthorized devices are identified.
*This news alert has been prepared by Med-Net Concepts, Inc. for informational purposes only and is not intended to provide legal advice.*