Blood pressure measurement devices that have been validated for clinical accuracy as determined through an independent review process.
Uncontrolled high blood pressure (“BP”) is the leading risk factor for death and disability. The accurate measurement of BP is essential for the diagnosis and management of hypertension. One important aspect of accurate measurement is whether the BP measurement device has been validated for clinical accuracy.
To address this challenge, the American Medical Association (AMA) enlisted the National Opinion Research Center at the University of Chicago (NORC) to assist in the design and management of an independent process to determine which BP devices available in the U.S. meet the AMA’s established criteria to validate clinical accuracy (the “Validated Device Listing (VDL) Criteria”). An Independent Review Committee comprised of physician experts in the BP field assesses whether a BP device satisfies the VDL Criteria for validation of clinical accuracy. This independent review process results in a formal list of BP devices that have been validated for clinical accuracy (the “US Blood Pressure Validated Device Listing” or “VDL”).
More information regarding the VDL Criteria, governance structure, and requirements for BP device manufacturers to submit device documentation to the Independent Review Committee can be found on the Validation page.
How does the AMA process differ from the FDA process to approve blood pressure devices?