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Established Heart Survey Clinches First MDDT Qualification

Following US FDA's final guidance on Medical Device Development Tools last year, the agency announced the first such tool has been qualified and that stakeholders should expect a slew of MDDTs to be approved in the next few months, including ones that apply to wearable medical monitoring devices.

US FDA announced Oct. 24 it has given thumbs up to a 20-year-old cardiovascular questionnaire. It is the first Medical Device Development Tool (MDDT) to be formally qualified by the agency, meaning sponsors can now use it to support their heart =-device product submissions. The agency says this is only the first in a slew of such tools it expects to qualify soon with the goal of helping to get new products to market sooner.

The first MDDT, called the Kansas City Cardiomyopathy Questionnaire (KCCQ), was technically qualified by the agency on Oct. 19. The 23-item questionnaire has already been in use by...

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