FDA drafts guidance on cuffless blood pressure measuring devices

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has issued a draft guidance to assist manufacturers in submitting clinical performance testing to support premarket submissions for cuffless non-invasive blood pressure (BP) measuring devices.

FDA defines these products as “a non-invasive blood pressure measurement system that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through sensors.”

These devices are classified as Class II devices and are regulated under 21 CFR 870.1130 with the product code DXN.

Cuffless devices provide several advantages over traditional cuffed devices, including greater comfort and convenience, the ability to measure blood pressure without upper arm sizing or positioning, and the capability for continuous blood pressure monitoring over extended periods, according to an article titled “Cuffless Blood Pressure Measurement Devices: International Perspectives on Accuracy and Clinical Use” which appeared in the April 2025 issue of JAMA Cardiology.

The guidelines indicate that sponsors should provide a description of the device's intended use, the technology used in the device, and its operating principles.

For cuffless devices that have a new intended use or novel technological features raising different safety and effectiveness questions compared to previously approved cuffless non-invasive blood pressure measuring devices, a De Novo request or a premarket approval application (PMA) may be necessary.

To ensure a clear understanding of the device, the premarket submission should describe if the device is intended to provide intermittent or spot-checking measurements or continuous measurements; autonomous initiation of measurement acquisition or only on-demand initiation of measurements; and whether measurements should take place under resting conditions or other conditions.

The guidance “strongly” recommends that sponsors consult with staff from FDA’s Q-Submission program early, prior to conducting studies, to help determine the appropriate performance evaluation for the device.

FDA's recommendations for clinical performance testing vary and are based on the technological characteristics and intended use of the device. In general, FDA recommends that sponsors provide clinical performance data from tests assessing static conditions, stability, and responses to changes.

This data should support the device's accuracy for users in a seated, resting position, as outlined in the International Organization for Standardization (ISO) standard 81060-2.

The guidance also includes a chart titled “Clinical Performance Testing Description and Considerations,” which outlines various test types, including the static, stability, and change tests.

According to the JAMA article, as of 2022, FDA has cleared 510(k)s for four cuffless devices. These include Sotera Wireless’s ViSi, cleared in 2012, this device estimates blood pressure using electrocardiography (ECG) and photoplethysmography (PPG) measurements taken from the wrist; Caretaker Medical’s Caretaker, cleared in 2017, which estimates blood pressure by pulse wave analysis (PWA) from the finger; Med Tach’s BPro cleared in 2018, which estimates blood pressure by applanation tonometry from the wrist; and Biobeat Technologies’ Biobeat, cleared in 2019, which estimates blood pressure by PPG from the wrist and chest.

Notice; Draft guidance

FDA drafts guidance on cuffless blood pressure measuring devices

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