FDA Guidance on Cuffless Blood Pressure Measuring Devices 

The FDA officially released the draft guidance “Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation“ on January 23, 2026.  

This document provides a specialized framework for validating the accuracy and safety of cuffless technologies, such as smartwatches, rings, and continuous monitoring sensors, which derive blood pressure from signals like light (photoplethysmography) or force (tonometry) rather than an inflatable cuff.  

This draft guidance outlines FDA’s current thinking on how developers should conduct clinical performance testing and evaluation to support premarket submissions for cuffless BP measurement technologies. 

This type of guidance aims to: 

• Clarify how to test the clinical performance of cuffless BP devices; 

• Promote consistency and efficiency in FDA review of new submissions; 

• Provide recommendations on data collection and evaluation methods that reflect real-world use. 

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Key Recommendations in the FDA Cuffless Blood Pressure Guidance

• Target Scope: Applies to non-invasive systems that estimate systolic, diastolic, or mean blood pressure through sensors. It specifically targets devices under product code DXN. 

• Standardized Benchmarks: The FDA recommends that devices demonstrate a mean error of ≤ ±5.0 mmHg and a standard deviation of < 8.0 mmHg across all tests to meet accuracy standards. 

• Diverse Study Populations: Validation data must reflect demographic diversity, including age, BMI, and sex. Notably, it recommends that at least 25% of subjects fall into each category of the Monk Skin Tone scale to ensure sensors work across all pigmentations. 

• Trial Design: Evaluations should include testing for static accuracy, BP change detection, and stability over time. It suggests a minimum sample size of 85 participants for standard adult use. 

• Regulatory Path: The guidance encourages manufacturers to use the Q-Submission Program for early feedback on study protocols before beginning clinical trials. 

• Public Comment Period: The FDA is currently accepting public comments on this draft through March 24, 2026.  

Why It Matters 

Cuffless blood pressure technology (often using sensors in wearables like smartwatches, rings, patches, etc.) is rapidly expanding and has been sold directly to consumers, including in some cases without proper FDA authorization.  

The FDA move comes partly in response to: 

• Unauthorized devices on the market claiming to measure blood pressure without meeting regulatory standards. 

• Growing interest by manufacturers in wearable BP measurement features and regulatory uncertainty over how they should be evaluated. 

Regulatory Context and Scientific Background 

• Historically, the FDA has warned consumers against using unauthorized blood pressure devices, especially cuffless ones on wearables, because inaccurate readings can risk delayed diagnosis or improper treatment. 

• Some cuffless technologies have received FDA 510(k) clearance, such as a wearable device cleared for over-the-counter use, but that is separate from this new draft guidance on clinical evaluation. 

• Independent clinical and scientific groups (e.g., American Heart Association) have emphasized that many wearable cuffless BP devices are not yet proven accurate enough to diagnose or guide treatment, even if some devices are cleared by FDA. 

How MedEnvoy Can Support

MedEnvoy supports medical device manufacturers in navigating evolving FDA guidance by translating regulatory expectations into clear, actionable strategies. Our team provides end-to-end support across regulatory planning, FDA engagement, and clinical evidence development to help reduce uncertainty and avoid downstream delays. We assist with early FDA interactions, including premarket strategy and submission preparation. If you have any questions regarding this summary or the accompanying guidance document, we encourage you to reach out to our regulatory experts, here.