FDA head Gottlieb touts release of 1st medical device development tool

The FDA today announced its 1st qualified medical device development tool as part of the agency’s Medical Innovation Access Plan announced by Commissioner Scott Gottlieb earlier this year.

The tool is a 23-item questionnaire designed to measure health information which is reported directly by patients with heart failure. The questionnaire is intended to be used to help engineers building heart failure devices more efficiently and accurately quantify how their device could improve a patient’s quality of life, Gottlieb said.

“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. 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. Innovators can trust in advance that the agency has already found the outputs of these measures to be reliable,” Gottlieb wrote in an FDA press release.

The agency said it expects to qualify more medical device development tools in the future, with a particular interest in wearable technologies. Gottlieb stated that new tools have the potential to provide “fundamentally better ways of measuring clinical outcomes,” including tracking how devices or drugs affect physical performance or the function and output of organ systems.

In addition to the tool’s release, the FDA also released 3 new guidance documents: one covering delineation of its new “Breakthrough Devices Program” and 2 documents to help developers decide whether they need to submit a new 510(k) application before making changes to existing devices. Gottlieb clarified that the guidance does not alter its existing review standard.

“This improved clarity will help lower the barriers to innovation and improve patient care by reducing unnecessary submissions to the FDA for changes that could not significantly affect device safety or effectiveness, so patients can benefit from upgraded products more quickly. Many devices function as tools in the hands of physicians. They benefit from feedback from doctors that helps innovators make small adaptations to improve a device’s performance. A regulatory framework that fosters this kind of useful revision is a key to improving their safety and performance,” Gottlieb said in a prepared statement.

The federal watchdog will continue to release new steps as it looks to improve device innovation speed alongside safety and effectiveness, Gottlieb said.

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