On Tuesday, FDA Commissioner Scott Gottlieb, M.D. announced new steps the FDA is taking to expedite access to approved medical devices for patients and providers.
The new steps are part of the FDA’s previously announced Medical Innovation Access Plan, a program focused on advancing personalized digital health technologies outside of traditional care settings. One of the most exciting pieces of the announcement was the unveiling of a new medical device development tool (MDDT) designed specifically for cardiovascular health:
Today’s newly qualified MDDT is a 23-item questionnaire that measures health information that is reported directly by patients with heart failure. The tool can be used to measure a heart failure patient’s health status, including clinical symptoms and the physical and social limitations caused by this condition. Such a tool has the potential to help engineers designing heart failure devices to more efficiently and accurately quantify how much their device could actually improve a patient’s quality of life.
Three new guidance documents were also announced. The first is a guidebook to the FDA’s “Breakthrough Devices Program,” while the others are intended to “help innovators determine when they need to submit a new 510(k) prior to making a change to a legally-marketed device subject to premarket notification (510(k)) requirements.”
The FDA plans to reveal full details of the Medical Innovation Access Plan in the near future.