Trust Through Verification: What the AMA Validated Device List Means for Blood Pressure Devices

Why Verification Matters in BP Devices 

Blood pressure (BP) measurement is a foundation of cardiovascular care. But not all BP devices are created equal — increasingly, clinicians and patients recognize that a blood pressure reading is only useful if it’s accurate. 

To address market confusion around which BP monitors are reliable, the American Medical Association (AMA) introduced the Validated Device Listing (VDL). The VDL is a free resource that helps clinicians, health systems, and patients find automated BP devices that have undergone independent review and meet a rigorous standard of clinical accuracy. 

What is the VDL Exactly? 

• The VDL is not a sales platform as it does not sell or distribute devices but rather lists models that satisfy clinical accuracy criteria.  

• Inclusion is voluntary. Manufacturers submit devices for review by an Independent Review Committee (IRC).  

• The IRC is composed of physician and measurement-device experts who assess whether submitted verification data meets the VDL Criteria (a set of clinical, technical, and reporting standards).  

• National Opinion Research Center at the University of Chicago (NORC) runs the submission and review infrastructure, including a submission portal and administrative oversight, on behalf of AMA.  

To date, the VDL includes dozens of validated BP device models (upper-arm, wrist, ambulatory, etc.). Currently devices worn on the finger are not included on the VDL.  

The VDL also provides tools and resources (website templates, infographics, and publications) featuring evidence-based content to promote accurate blood pressure measurement and effective hypertension management. 

The VDL Criteria: What Devices Must Demonstrate 

To be eligible for VDL listing, a BP device must satisfy several components of the VDL Criteria. Key requirements include: 

Criterion	Summary	Notes
Active FDA 510(k) Clearance	The device must already be cleared for medical use in the U.S.	This ensures existing regulatory baseline.
Internationally   Accepted Protocols	All verification studies should follow internationally accepted protocols to ensure consistency, credibility, and regulatory alignment.	Accepted protocols include versions of ANSI/AAMI/ISO 81060-2:2018, BHS Revised Protocol, or SP10.
Independent Verification Data	Documentation should be provided from peer-reviewed publications or independent third-party verification from qualified research institutions.	Qualified third parties include credible research organizations with proven expertise in the relevant verification protocols and study requirements. Manufacturer-conducted verification is insufficient unless independently verified by a qualified third party.
Cuff Size Coverage	The submitted device must have been validated across cuff sizes appropriate for intended populations (e.g. small, standard, large).	If a device offers multiple cuffs, they need proper verification or justification.
Equivalent Model Documentation	If the model submitted is a variant (e.g. same electronics but different enclosure), the manufacturer must demonstrate equivalence (e.g. same measurement core).	Prevents trivial cosmetic variants from bypassing verification.

The complete criteria, including performance thresholds and reporting standards, are publicly available via the VDL documentation.  

There are no fees for the review process, and manufacturer submissions are accepted by NORC on a rolling basis for IRC evaluation.  The AMA does not receive funding from blood pressure device manufacturers or any other third parties. Importantly: inclusion in the VDL is not an AMA endorsement.  

Why Getting on the VDL Is Strategically Valuable 

For manufacturers and MedTech firms, listing on the VDL offers several advantages: 

1. Credibility and trust. Being listed signals to clinicians, hospitals, and patients that a device met an independent, high bar for accuracy. 

2. Market differentiation. In a crowded BP device market, a validated status can distinguish your product from others that lack clinical verification. 

3. Support for reimbursement/procurement. Health systems and users may favor solutions with documented clinical accuracy. They are more comfortable selecting devices from a trusted, validated list. 

4. Clinical guideline alignment. Current hypertension guidelines place increased emphasis on using validated BP devices; referencing the VDL helps manufacturers align with clinician expectations. 

5. Transparency and risk mitigation. The VDL process is independent, structured, and publicly documented. 

How to Get a Device Listed on the VDL: Step-by-Step 

If you are a manufacturer or sponsor, here is a roadmap to prepare and submit a device for VDL consideration: 

1. Confirm regulatory eligibility. Verify your device has an active FDA 510(k) clearance for its intended indication. Without that, you cannot submit. 

2. Plan and execute independent verification. Design clinical verification studies, identify prior published, and/or previously third-party independently conducted studies that follow an accepted protocol (e.g. ISO 81060-2) and meet performance thresholds. Include adequate sample size, cuff coverage, and subject diversity. 

3. Assemble supporting documentation. Prepare a submission package with: 

4. Clinical study report(s) 

5. Methodological details (statistical plan, protocol) 

6. Cuff sizing documentation 

7. Equivalence justification (if model variants) 

8. Device labeling and specs 

9. Submit via the VDL portal. Use the online submission system.  

10. Peer review & committee decision. The IRC assesses compliance with the VDL Criteria. If approved, the device is added to the list. 

11. Ongoing compliance & updates. If your device changes (hardware, firmware, cuff design), you may need to resubmit or justify equivalence. Also, new devices can be submitted at any time.  

How PRL Can Help Medtech Teams Navigate the VDL Journey 

At Parameters Research Laboratory (PRL), our experience in physiological monitoring, device verification, and regulatory science positions us as an ideal partner to support VDL submissions: 

• Protocol design and statistical planning. We can help you design verification studies aligned with accepted protocols (e.g. ISO 81060-2) and optimized to satisfy VDL performance requirements. 

• Clinical execution & data collection. Our lab operations and CRO infrastructure enable high-integrity data generation under GCP / ISO-compliant conditions. 

• Independent third-party verification. We can act as an independent partner to ensure that your submissions to VDL are objectively credible. 

• Submission preparation. PRL can assist in assembling the verification report, documentation package, and verifying completeness. 

• Regulatory alignment & risk mitigation. We help you anticipate reviewer questions, ensure that your data satisfies both FDA and VDL expectations, and manage the submission timeline. 

By partnering with us, you can streamline your path to listing, reduce technical risks, and improve your device’s credibility in clinical markets. 

Conclusion & Call to Action 

The AMA Validated Device List (VDL) fills a critical gap: offering a trustworthy, independent benchmark of clinical accuracy for BP devices. For manufacturers and innovators in the medical device space, achieving VDL listing can unlock competitive and regulatory and advantages. 

However, it requires rigorous verification, strong documentation, and alignment with exacting criteria. At PRL, we are uniquely positioned to guide MedTech teams through the verification, submission, and audit processes. 

Interested in getting your device listed on the AMA VDL? Contact us to review your current verification strategy, identify gaps, and plan toward successful submission.

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