U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb announced on October 24 that the agency is preparing to release a new medical device development tool and will also release new guidance documents, both designed to promote medical device innovation.
The tool is part of the agency's Medical Innovation Access Plan, announced earlier this year, and it will provide a more objective platform for developing devices in cardiovascular health, Gottlieb said. The tool is a 23-item questionnaire that measures health information reported directly by patients with heart failure. It can be used to measure a heart failure patient's health status, including clinical symptoms and the physical and social limitations caused by the condition.
The questionnaire could help engineers designing heart failure devices to more efficiently and accurately quantify how much their device could improve a patient's quality of life, the FDA said. By qualifying the tool under the FDA's new voluntary program, product developers can more easily rely on the tool's output as part of their development plans.
The agency expects to evaluate and qualify more medical device development tools in the coming months, such as for wearable technologies.
The FDA also released three new guidance documents related to medical devices: a draft guidance delineating the FDA's new Breakthrough Devices Program, and two documents on helping innovators determine when they need to submit a new 510(k) prior to making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 requirements.
The Breakthrough Devices Program is intended to help patients more quickly access certain devices that effectively diagnose or treat life-threatening or irreversibly debilitating diseases or conditions, such as technologies that have no alternative or that offer a significant advantage over FDA-cleared or approved alternatives.
