US FDA finalises new guidelines for medical device development

26 October 2017 (Last Updated October 27th, 2017 10:40)

The US Food and Drug Administration (FDA) has announced new measures to promote medical device innovation and provide patients with fast access to beneficial technologies.

The US Food and Drug Administration (FDA) has announced new measures to promote medical device innovation and provide patients with fast access to beneficial technologies.

In addition to establishing modern tools for measurement of device safety and performance, the new steps include three new guidance documents to allow efficient and predictable development.

The organisation has completed the first qualification of a medical device development tool (MDDT), which is a 23-item questionnaire designed to measure health information such as health status and clinical symptoms reported by heart failure patients.

MDDT is intended to aid designing of heart failure devices for accurate and efficient quantification of the device to ensure actual improvement in a patient’s quality of life.

FDA commissioner Scott Gottlieb said: “By qualifying the tool under the FDA’s new, voluntary programme, 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.”

“Innovators can trust in advance that the agency has already found the outputs of these measures to be reliable.”

The organisation recommends development of such medical device tools, primarily for wearable technologies, to potentially avoid animal studies, minimise testing time and improve ability to analyse benefit and risk.

Created by the 21st Century Cures Act, the first new draft guidance by the FDA is Breakthrough Devices Programme to offer quick access to certain devices that could effectively diagnose or treat life-threatening or irreversibly debilitating diseases or conditions.

The programme is expected to make the pre-submission process faster for the breakthrough devices.

Intended to address new 510(k) submissions, the two final guidance documents will help in understanding when a modification to a legally-marketed device requires new premarket clearance.

While the guidelines do not change the review standard of the FDA, they are said to improve predictability and consistency for innovators by eliminating the need for submissions on changes that could not significantly affect device safety or effectiveness.