US Blood Pressure Validated Device Listing
Submission

VDL™ Criteria

The AMA convened experts with relevant technical and clinical practice expertise to develop a set of criteria (VDL Criteria) to aid in determining which automated blood pressure (BP) measurement devices in the United States have been validated for clinical accuracy. The VDL Criteria were refined and finalized with input from key stakeholders including clinicians, health care organizations, BP device manufacturers, and the Food and Drug Administration (FDA).

The VDL Criteria apply to BP devices for use in clinical, community, or home settings. These BP devices must meet the following criteria to be formally listed on the VDL:

  1. Part I
    1. Automated devices with cuff sizes tested with and available for the intended population
  2. Part II
    1. Active FDA 510(k) pre-market clearance record and documentation
    2. Documentation of independent validation testing (provided by a qualified third party or peer-reviewed publication) following one of these accepted protocols:
      1. ISO 81060-2:2018
      2. ANSI/AAMI/ISO 81060-2: 2013
      3. ANSI/AAMI/ISO 81060-2: 2009
      4. ANSI/AAMI SP10: 2002
      5. BHS Revised Protocol: 1993
  3. Part III
    1. Documentation that a device is an equivalent model variant

The complete VDL Criteria can be viewed here:

Download VDL Criteria

VDL™ governance

To ensure an independent, objective, and transparent process, the AMA has convened committees of leaders and experts to provide governance and oversight of the US Blood Pressure Validated Device Listing (VDL).

Advisory Group

The Advisory Group provides insights and recommendations on industry trends, emerging technologies, and regulations related to BP devices and testing protocols, as well as essential input on clinical and consumer perspectives. The group is currently comprised of the representatives from the following organizations: American College of Cardiology, American College of Physicians, American Heart Association, American Pharmacists Association, CDC/CMS Million Hearts, Columbia University Hypertension Center, Consumer Technology Association, Food & Drug Administration, National Medical Association, Preventative Cardiovascular Nurses Association and Stanford Hypertension Center.

Independent Review Committee

An independent review of device qualifications by a committee of experts is vital to determining which BP measurement devices are included on the VDL. This Independent Review Committee is comprised of experienced, qualified professionals who review manufacturer submissions for consideration. After careful independent review, the experts convene and come to consensus regarding final determinations on which BP devices meet the VDL Criteria, and therefore qualify to be listed on the VDL.

Members of the Independent Review Committee must have relevant expertise, as demonstrated by any combination of the following:

  • Extensive publication history on topics related to BP device testing, measurement, and clinical impact.
  • Knowledge of international validation protocols for BP devices – prior experience conducting clinical testing with BP devices or similar medical devices.
  • Prior experience conducting clinical testing with BP devices or similar medical devices
  • Prior experience reviewing documentation in certification, standards development, and clinical trials, in a similar capacity.
  • Photograph of Atul Bali,

    Atul Bali,
    MD

    Geisinger Wyoming Valley Medical Center

  • Photograph of Tammy Brady,

    Tammy Brady,
    MD | PhD; IRC Co-chair.

    Johns Hopkins University School of Medicine

  • Photograph of Jennifer Cluett,

    Jennifer Cluett,
    MD

    Harvard Medical School

  • Photograph of Jordana Cohen,

    Jordana Cohen,
    MD | MSCE; IRC Co-chair.

    University of Pennsylvania

  • Photograph of Richard Dart,

    Richard Dart,
    MD | MACP | FAHA

    Marshfield Clinic

  • Photograph of Maria Delgado- Lelievre,

    Maria Delgado- Lelievre,
    MD

    University of Miami Soffer Clinical Research Center

  • Photograph of Beverly Green,

    Beverly Green,
    MD | MPH | FAHA | FASH;

    Kaiser Permanente Washington Medical Group

  • Photograph of Michael Gutkin,

    Michael Gutkin,
    MD

    Saint Barnabas Medical Center (retired)

  • Photograph of Stephen Juraschek,

    Stephen Juraschek,
    MD

    Beth Israel Deaconess Medical Center

  • Photograph of Timothy Plante,

    Timothy Plante,
    MD | MHHS

    University of Vermont

  • Photograph of Sandra Taler,

    Sandra Taler,
    MD | FAHA

    College of Medicine, Mayo Clinic

  • Photograph of George Thomas,

    George Thomas,
    MD

    Cleveland Clinic

  • Photograph of Ray Townsend,

    Ray Townsend,
    MD

    University of Pennsylvania

  • Photograph of Wanpen Vongpatanasin,

    Wanpen Vongpatanasin,
    MD

    University of Texas- Southwestern

  • Photograph of William B. White,

    William B. White,
    MD | FAHA

    University of Connecticut

Members have no declared conflicts of interests.

Contact us for more information on the Independent Review Committee, including terms and process to be considered for membership.

Submit a device for review

It is essential to providers and patients that the VDL contains all validated devices currently available on the market. Device manufacturers, and organizations with manufacturing partners, are strongly encouraged to review the VDL Criteria and submit the required documentation for consideration. The VDL will be updated following each Independent Review Committee cycle to include all BP devices that meet the VDL Criteria.

Manufacturers may now submit their BP device information for review by the Independent Review Committee at any time. Contact VDLsubmission@norc.org to receive instructions for submission.

Contact for Submission Download VDL Criteria
An invitation from the National Opinion Research Center at the University of Chicago (NORC), and potential acceptance on US Blood Pressure Validated Device Listing ("VDL"), does not constitute an endorsement of a BP device manufacturer’s company, products, or services by the American Medical Association ("AMA"). Manufacturers, their affiliates, and any of their partners are prohibited from using the AMA and NORC names, logos, or trademarks in any marketing or promotional materials, including but not limited to press releases, blogs, advertising materials, or other similar publications, whether written or oral. Manufacturers will receive additional guidelines if any of their devices are approved for listing on the VDL by the Independent Review Committee.