In a statement, U.S. FDA Commissioner Scott Gottlieb, MD, revealed that the FDA has completed its first qualification of a medical device development tool (MDDT) to provide a more objective platform for developing devices in a key area of medicine: cardiovascular health. Such a development comes on the heels of the FDA’s August final guidance document regarding how the agency qualifies an MDDT.
“At the FDA, we’re undertaking a comprehensive policy effort to facilitate the development and validation of these kinds of medical device development tools,” Gottlieb said in a statement. “[The] newly qualified MDDT is a 23-item questionnaire that measures health information that is reported directly by patients with heart failure.”
Gottlieb added that the tool can be used to evaluate 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,” Gottlieb said. “By qualifying the tool under the FDA’s new, voluntary program, it will make it easier for product developers to rely on the outputs of this newly qualified tool as part of their development plans.”
He said that FDA officials expect to evaluate and quality more medical device development tools in the next few months and “encourage this kind of product development.” Wearable technologies, Gottlieb said, are particularly interesting to FDA officials.
After all, he maintained: “The development of more modern tools for measuring outcomes relevant to regulatory decisions is a key part of our efforts to promote innovation. Such development tools can also help minimize the use of animal studies, reduce the duration of testing, or require fewer patients in a study by optimizing patient selection or improving on the ability to measure benefit and risk through the availability of measurements that are more sensitive for assessing these outcomes.”