KCCQ Approved by FDA for Regulatory Submissions for Heart Failure Medical Devices

24 October 2017 - 21:41

In a crucial endorsement of the validity and reliability the KCCQ, the US Food and Drug Administration has qualified the KCCQ to be used by medical device companies to support regulatory submissions for heart failure medical devices. Sponsor/investigators may use KCCQ data to establish safety and effectiveness of such devices. As detailed in the FDA annoucement, KCCQ scale scores “can be used as a component of a composite primary endpoint or secondary endpoint in a feasibility or pivotal clinical trial evaluating heart failure medical devices. The instrument can be used in superiority and non-inferiority trials evaluating out­ patients or in-patients with heart failure syndrome. For in-patient studies, post-discharge outcomes could be helpful to define the health status benefits of treatment.”

The KCCQ underwent extensive scrutiny as part of the FDA’s voluntary Medical Device Development Tools (MDDT) program. Indeed, the KCCQ was the first such tool qualified under the MDDT program. As Hilda F. Scharen, M. Sc., Capt. USPHS, and Jeffrey Shuren, M.D., J.D. explain: “The KCCQ can assess whether a patient perceives that their heart failure symptoms have improved following an intervention. These results can then be used as part of the benefit/risk assessment to help determine a device’s safety and effectiveness.”

John Spertus, MPH, MD, author of the KCCQ, states: “We are gratified by the FDA’s recognition of the KCCQ’s important characteristics and hope that it will elevate the quality of heart failure devices and improve the health status of all patients who receive them.”


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