The CORolla device from Israel-based CorAssist is one example of new devices being manufactured and tested to treat heart failure. The efficacy of this and other new devices under development can now be assessed with the Minnesota Living With Heart Failure Questionnaire.
May 7, 2018 — The U.S. Food and Drug Administration (FDA) has qualified the Minnesota Living with Heart Failure Questionnaire from the University of Minnesota as part of the Medical Device Development Tools (MDDT) program. This voluntary program is intended to reduce regulatory burden for medical device developers and FDA reviewers by qualifying tools that can aid in the development and evaluation of medical devices. Tools qualified by the FDA can be used by the medical device industry to support device submissions, which could reduce time and resources involved in product development.
The Minnesota Living with Heart Failure Questionnaire is comprised of 21 self-administered questions designed to measure the adverse effects of heart failure on patients’ lives. The patient receives a brief set of instructions, and then uses a scale from zero to five to indicate how much each dimension of heart failure has affected their life over the previous four weeks. The questionnaire asks patients to rate the following dimensions of quality of life:
1) Physical symptoms and signs of heart failure;
2) Common physical/social functions;
3) Psychosocial and cognitive function; and
4) Overall adverse impact on quality of life.
The questionnaire can be used to determine whether a device is effectively treating or improving patients’ quality of life by reducing the adverse impact of heart failure. The instrument can be used as a secondary endpoint in feasibility and pivotal studies of outpatients with symptomatic (New York Heart Association class II and III) heart failure. The questionnaire may be used by medical device companies and sponsor-investigators in controlled clinical trials designed to test superiority or non-inferiority of medical devices in support of regulatory submissions.
When used within the qualified context of use, manufacturers and sponsors do not have to justify their use of the tool, and FDA review staff can accept the use of the tool without the need to reconfirm its suitability and utility.
FDA qualification of a medical device development tool is different from FDA clearance or approval of a medical device. The type of evidence needed to support qualification is not the type of evidence that is needed to support marketing authorization for a medical device.
More information about the Minnesota Living with Heart Failure Questionnaire, including how to access the tool, is available in the Summary of Evidence and Basis for Qualification. More information about the medical device development tools program is available on the FDA’s Medical Device Development Tools webpage. Additional tools will be added to the webpage once they are qualified.
For more information: www.fda.gov