FDA Draft Guidance on Cuffless Blood Pressure Devices: What It Says—and What It Signals

A Familiar Framework with Important Regulatory Implications 

In January 2026, the FDA released a draft guidance titled “Cuffless Non-Invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation.” The document outlines FDA’s current recommendations on how cuffless blood pressure (BP) devices—both intermittent and continuous—should be clinically evaluated to support premarket submissions. 

For developers already working in this space, the guidance will feel familiar. Much of it aligns closely with existing practice and FDA-recognized consensus standards. However, there are several important signals worth noting, particularly around study design expectations, demographic representation, and future regulatory scrutiny. 

Scope of the FDA Draft Guidance (Cuffless BP) 

The guidance applies broadly to cuffless, non-invasive blood pressure measuring systems, generally regulated as Class II devices under 21 CFR 870.1130 (product code DXN). Both: 

• Intermittent (spot-check) cuffless BP devices 

• Continuous cuffless BP devices 

are explicitly within scope. 

Traditional cuff-based devices and neonatal ICU continuous monitors are excluded. FDA emphasizes that developers must clearly describe the cuffless blood pressure device;s intended use, including: 

• whether measurements are continuous or intermittent (spot-check) 

• autonomous or user-initiated 

• limited to measurements during resting conditions or extended to sleep, ambulatory conditions, or other body positions 

Alignment with Existing Consensus Standards 

A central theme of the guidance is harmonization with established standards, rather than the introduction of new methodologies. FDA recommendations draw heavily from: 

• ISO 81060-2 (intermittent automated BP measurement) 

• ISO 81060-3 (continuous automated BP measurement) 

• IEEE 1708a:2019 (wearable, cuffless BP devices) 

  
  

FDA explicitly notes where portions of IEEE 1708 are not fully recognized and directs sponsors back to ISO 81060-2 methodologies and acceptance criteria in those cases. 

In practice, this reinforces what many regulatory-grade CROs already implement: hybrid protocols that prioritize ISO-based statistical rigor while incorporating cuffless-specific considerations. 

Study Structure and Oversight 

FDA recommends clinical validation studies that reflect the device’s intended use, technological characteristics, and calibration approach. These studies are generally considered nonsignificant risk and must follow good clinical practice (GCP) with IRB approval and informed consent. 

Early engagement through the FDA’s Q-Submission Program is strongly encouraged, particularly for devices incorporating machine learning or autonomous measurement. 

Sample Size, Demographics, and Monk Skin Tone Representation 

For adult devices intended for ages 21–50, FDA recommends: 

• At least 85 participants 

• Minimum 30% female and 30% male representation 

  
  

For special populations (e.g., adults over 50, pediatric populations, arrhythmias, pregnancy), FDA recommends at least 85 additional participants per subgroup, with further increases if needed to assess confounding effects.

Notably, the guidance includes specific expectations for skin tone representation, recommending stratification using the Monk scale with at least 25% enrollment in each of the three major groupings (Monk 1–4, 5–7, and 8–10). This mirrors broader FDA emphasis on inclusive participant recruitment. 

Reference Determinations 

Manual Auscultation Reference (Intermittent Devices) 

For intermittent cuffless blood pressure devices, performance evaluation should conducted using manual auscultatory reference measurements. Dual-listener auscultation is standard, with each blood pressure reading independently verified by two trained observers using a double stethoscope. This approach ensures accurate reference determination for discrete, cuff-based reference measurements consistent with ISO 81060-2. 

Intra-Arterial Reference (Continuous Devices) 

Continuous cuffless blood pressure devices should be evaluated against intra-arterial blood pressure measurements, which provide a direct, beat-to-beat reference standard. This validation approach aligns with the requirements outlined in ISO 81060-3 for continuous blood pressure measurement systems. 

Performance Tests: Static, Stability, and Change 

FDA outlines three core performance evaluations, consistent with ISO frameworks: 

Static Test 

Demonstrates accuracy following device setup or initialization. 

Stability Test 

Assesses accuracy across the labeled window of validity for devices that rely on initialization or memory of prior measurements. The FDA recommends assessing device performance at multiple time points, including at the middle and end of the initialization period, and incorporating circadian variation when feasible. 

Change Test 

Evaluates performance following blood pressure changes relative to the initialization point. FDA specifies thresholds for “large” systolic and diastolic changes and recommends that at least 30% of measurements represent increases and 30% represent decreases. 

Additional Testing 

If the intended use includes alternative body positions or use during ambulation, exercise, sleep, transport, or autonomous operation, additional testing considerations may apply. 

Acceptance Criteria 

FDA recommends the familiar ISO 81060-2 -based acceptance criteria for each test type, including Static, Stability, and Change, and for each intended patient population. For the Change test, acceptance criteria should be applied only to the subset of subjects who achieve the required change in blood pressure. 

• Criterion 1: A mean error of ≤ ±5.0 mmHg with a standard deviation of < 8.0 mmHg. 

• Criterion 2: Acceptance is determined by the relationship between mean error and standard deviation, where the maximum allowable standard deviation is defined as a function of the observed mean error. 

What’s Not Included (and When FDA May Ask for More) 

The FDA clearly states that the document does not include the totality of information required for a premarket submission and hints that additional considerations may apply depending on device design and intended use.  This language leaves room for FDA to request: 

• Additional datasets 

• Expanded population coverage 

• Supplemental performance testing 

Such requests may be more likely for novel technologies or devices seeking broader indications for use. 

Conclusion 

For teams already aligned with ISO 81060-2, -3, and IEEE 1708a, this draft guidance largely confirms current best practice rather than redefining it. Its real value lies in: 

• Clarifying FDA’s expectations for cuffless blood pressure validation 

• Reinforcing demographic and skin tone representation requirements 

• Emphasizing early regulatory engagement  

  
  

The FDA’s January 2026 draft guidance on cuffless blood pressure devices is concise, pragmatic, and intentionally aligned with existing standards. While it introduces few new requirements, it formalizes expectations that many developers already encounter and reinforces that validation of cuffless blood pressure technologies will remain an area of focused regulatory scrutiny. 

At Parameters Research Laboratory (PRL), we support cuffless blood pressure device validation through ISO and FDA aligned protocols, inclusive recruitment strategies, and CRO transparency, helping teams generate regulator-ready clinical endpoints while minimizing submission risk. Contact us today. 

*See Disclaimer regarding AI-generated content