ISO 81060-7 and FDA Guidance for Wearable Blood Pressure Devices

The Rise of Wearable Blood Pressure Devices 

Advances in sensor technology and signal processing have accelerated the development of wearable and cuffless blood pressure devices, including systems designed for intermittent spot checks and those that aim to estimate blood pressure more frequently over time.  

Unlike traditional cuff-based monitors, wearable and cuffless technologies must perform under real-world conditions where movement and posture can influence measurements. As a result, validation approaches for wearable blood pressure devices increasingly focus on intended use conditions as well as accuracy. 

What ISO 81060-7 Addresses 

ISO 81060-7 is being developed to provide a clinical performance framework for intermittent and repeated intermittent cuffless blood pressure measurement devices. While the standard remains under development, it is expected to help define how wearable and cuffless technologies should be evaluated in clinical research settings. 

For device developers, this creates a more structured path for study design. Validation protocols may need to consider: 

• Measurement conditions that reflect the device labeling, such as rest, posture, or other intended-use scenarios 

• Repeated time points or study visits to evaluate performance over the calibration period  

• Planned participant distributions, ensuring performance is evaluated across a range of blood pressures and participant demographics 

  
  

These considerations are especially important for wearable technologies that rely on indirect signals rather than traditional cuff inflation. 

FDA Draft Guidance and Cuffless BP Validation 

FDA’s draft guidance on cuffless non-invasive blood pressure measuring devices reinforces the need for structured clinical performance testing. The guidance outlines FDA’s current recommendations for supporting premarket submissions and encourages study designs that reflect the device’s intended use. 

Key themes include: 

• Clearly defined intended use conditions  

• Evaluation of static performance, stability over time, and performance after blood pressure change  

• Prespecified sample size and subgroup strategies  

• Inclusive enrollment and documentation of participant characteristics, including the Monk Skin Tone Scale when relevant 

• Early FDA engagement when device algorithms, calibration methods, or automated features add complexity 

  
  

Together, ISO 81060-7 and FDA’s draft guidance point toward the same central expectation: wearable blood pressure validation should be designed around how the device will be used. 

Supporting Wearable Device Validation 

Clinical studies for wearable and cuffless blood pressure devices require careful planning, controlled procedures, and clear documentation. Study protocols should define the reference method, measurement conditions, participant population, calibration approach, and performance endpoints before data collection begins. 

By evaluating accuracy, stability, and change performance under defined use conditions, these studies generate clinical evidence that can support medical device validation and regulatory submissions. 

Parameters Research Laboratory supports wearable blood pressure device developers with structured clinical research protocols designed around ISO standards and FDA expectations. As wearable blood pressure technologies continue to evolve, strong validation planning will remain essential for building reliable, regulator-ready evidence. Ready to talk about your study? Contact us today!