FDA Drafts Testing Standards for Cuffless Blood Pressure Devices

The US Food and Drug Administration has issued draft guidance setting out the clinical performance testing it expects for cuffless blood pressure measuring devices, a category that measures pressure through sensors rather than an inflatable cuff. The draft guidance document is dated January 23, 2026, and a notice of availability appeared in the Federal Register the same day. Regulatory Focus reported the draft on January 22, when the agency posted it.

According to the notice, the draft "provides recommendations for clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring devices." Comments are due by March 24, 2026, under docket FDA-2025-D-0851, according to the FDA's guidance page.

Scope and pathway

The draft covers cuffless systems regulated under 21 CFR 870.1130, product code DXN, which the FDA says have generally been classified as class II devices. Cuff-based devices under the same product code and neonatal intensive care unit continuous monitors under product code QYF are outside its scope, the document says.

For cuffless devices with a new intended use or novel technological features that raise different safety and effectiveness questions, a De Novo request or premarket approval application may be necessary, Regulatory Focus reported. The guidance "strongly" recommends that sponsors consult FDA staff through the Q-Submission program before conducting studies, according to the outlet.

Three kinds of tests

The FDA recommends that sponsors submit clinical performance data from static, stability and change tests, when applicable. The static test is intended to show accurate measurements following device setup. A stability test is recommended for devices that rely on initialization with a known blood pressure reading or on memory of a previous state, and should cover the time window stated in the labeling. In the draft's example, a device initialized with a cuff reading and labeled accurate for 28 days would be tested on Day 1, around Day 14 and again on Day 28.

The change test is intended to show accuracy after blood pressure changes. The draft defines large changes as systolic values at least 15 mmHg and diastolic values at least 10 mmHg above or below the initialization point, and recommends that at least 30% of measurements be large increases and at least 30% large decreases.

For each test and population, the draft's first acceptance criterion is a mean error of no more than ±5.0 mmHg with a standard deviation below 8.0 mmHg, citing the FDA-recognized ISO 81060-2 standard. A second criterion sets the maximum allowable standard deviation as a function of the measured mean error.

Who must be in the studies

The draft typically recommends at least 85 additional participants for each special population in a device's intended use, listing examples such as adults over 50, pediatric subgroups, people with arrhythmias, people on vasoactive drug therapy and pregnant women. For devices intended for adults over 50, it recommends enrolling at least 85 subjects in that group, with at least 20% in the uppermost decade. It also recommends enrolling at least 25% of participants in each of the Monk Skin Tone ranges 1-4, 5-7 and 8-10, or an equivalent scale.

Regulatory Focus cited a JAMA Cardiology article reporting that, as of 2022, the FDA had cleared 510(k)s for four cuffless devices, from Sotera Wireless, Caretaker Medical, Med Tach and Biobeat Technologies.