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# Draft Guide on Blood Pressure Monitoring Sensors
- URL: https://www.fdaweb.com/draft-guide-on-blood-pressure-monitoring-sensors/
- Published: 2026-01-22T12:00:00.000Z
- Updated: 2026-09-14T15:31:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160526

FDA has issued a [draft guidance](https://www.fda.gov/media/190675/download?ref=fdaweb.com) laying out detailed expectations for how makers of cuffless, non-invasive blood pressure monitoring devices should test and validate their products before seeking market clearance. The document focuses on clinical performance testing for a fast-growing class of devices that estimate blood pressure without the traditional inflatable cuff, often using wearable sensors and algorithms. The agency says the guidance is intended to clarify how manufacturers can demonstrate accuracy and reliability in premarket submissions, particularly as the technology becomes more complex and increasingly incorporates software-driven models.

Under the draft guidance, cuffless blood pressure devices generally fall into the Class 2 category and are regulated as noninvasive blood pressure measurement systems. Traditional cuff-based monitors and certain neonatal intensive care devices are excluded. Companies are advised to clearly describe a device’s intended use, technology, and operating principles, including whether it provides spot-check or continuous readings, operates autonomously, functions during movement or sleep, or requires calibration using prior measurements or personal data.

The draft calls for robust clinical validation studies that reflect real-world use of the device. In most cases, FDA recommends testing in at least 85 adult participants, with balanced representation by sex, and additional cohorts for special populations such as older adults, pediatric patients, people with arrhythmias, pregnant women, or individuals receiving vasoactive medications. The agency also highlights the importance of enrolling participants across a range of skin tones, ages, body mass indexes, and other demographic factors that could affect device performance.

For devices that rely on algorithms or artificial intelligence, FDA notes that additional sample size considerations may be necessary and urges manufacturers to describe how models are trained, tuned, and validated. Developers are encouraged to engage early with the agency through the Q-Submission program to obtain feedback on study design before launching clinical testing.

To support accuracy claims, the guidance recommends three core types of performance testing: static tests to assess accuracy shortly after device setup, stability tests to confirm accuracy over the labeled period of use, and change tests to evaluate performance when blood pressure rises or falls significantly from an initial calibration point. Depending on the device, testing may involve comparisons with manual auscultation or arterial line measurements, following methods described in internationally recognized standards.

The agency points manufacturers to consensus standards such as IEEE Standard 1708 and International Organization for Standardization standards ISO 81060-2 and ISO 81060-3, while also flagging specific portions of those standards that FDA does not recognize and recommending alternative approaches.

Additionally, FDA proposes acceptance criteria consistent with existing blood pressure standards, including limits on mean measurement error and variability. Devices would need to meet those benchmarks across all relevant tests and patient populations to support clearance.