The Importance of FDA-Approved Blood Pressure Monitors

Blood Pressure Monitoring: A Clinical Cornerstone 

Blood pressure measurement is one of the most common clinical assessments, shaping decisions in nearly every healthcare setting. However, not all blood pressure monitors provide the accuracy needed for safe clinical use. FDA-approved devices stand apart by meeting strict accuracy standards backed by international validation protocols and clinical research studies. 

In the United States, most blood pressure monitors aren’t formally "approved" but rather cleared by the FDA under the 510(k) pathway. That means they’re deemed safe and perform on par with existing devices on the market. Additionally, many experts recommend using devices listed in the U.S. Blood Pressure Validated Device Listing (VDL), maintained by the AMA, to ensure they meet rigorous validation standards.  Devices listed on the VDL have been cleared by the FDA.  

The Risks of Non-Validated Blood Pressure Devices 

Unregulated or consumer-only blood pressure monitors may lack the precision to detect subtle but clinically significant changes. Inaccurate readings can: 

• Lead to mismanagement of hypertension or cardiovascular risk. 

• Undermine confidence in monitoring technology. 

• Delay clinical adoption of new devices lacking regulatory clearance. 

ISO Standards for Blood Pressure Validation 

FDA clearance requires evidence that devices meet international validation standards, including: 

• ISO 81060-2: Non-invasive sphygmomanometers—Part 2: Clinical investigation of automated measurement type. 

• ISO 81060-7: Non-invasive sphygmomanometers—Part 7: Clinical investigation of intermittent automated non-invasive sphygmomanometers. 

These studies often involve direct comparison to dual auscultation.  Using a double stethoscope, two trained clinicians listen together to Korotkoff sounds, ensuring highly accurate systolic and diastolic blood pressure readings. 

How Blood Pressure Monitors Get FDA 510(k) Clearance 

Most blood pressure monitors achieve FDA clearance through the 510(k) pathway, which requires manufacturers to demonstrate that their device is substantially equivalent to an already cleared monitor. To secure this clearance, companies must submit a detailed package that typically includes: 

• Bench testing results to confirm the device’s mechanical, electrical, and software safety. 

• Clinical validation data, often performed by specialized research labs like PRL, to prove measurement accuracy against gold-standard reference methods. 

• Risk analysis and labeling compliance to demonstrate the device meets FDA requirements for safe use and proper consumer guidance. 

By meeting these rigorous requirements, manufacturers not only achieve FDA 510(k) clearance but also build trust with regulators, healthcare providers, and consumers looking for clinically validated, reliable blood pressure monitors. 

PRL’s Expertise in Blood Pressure Device Validation 

At PRL, we design and conduct blood pressure validation studies aligned with FDA and ISO requirements. Our team provides: 

• Clinical trial protocol development to ensure compliance with ISO 81060-2 or ISO 81060-7. 

• Inclusive participant recruitment to evaluate device accuracy across diverse demographics. 

• Regulator-ready data alignment, analysis, and reporting streamlining FDA and CE mark submissions. 

Through strict adherence to GCP compliance and IRB oversight, we ensure both participant safety and regulator confidence in study results. By holding ourselves to these standards, we guarantee the highest quality data and meaningful outcomes for device validation. 

Conclusion: Ensuring Trust Through FDA Approval 

FDA-approved blood pressure monitors provide the accuracy needed for both clinical and at-home use, supporting better decision-making and safer care. Gaining FDA clearance signals more than regulatory approval, it tells the market you’re credible and built for lasting success. 

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