FDA Announces New Challenge Seeking Medical Devices That Will Help Combat the Ongoing Opioid Epidemic

Jun 8, 2018

In response to the ongoing opioid epidemic, the Food and Drug Administration (FDA) recently announced a new “innovation challenge” to encourage the development of new medical devices to help combat this issue. The challenge is seeking new medical devices, including mobile apps and computer software that can provide an alternate source of relief for treating addiction and pain than opioids.

In an FDA press release, FDA Commissioner Scott Gottlieb, M.D. said, “Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis. We must advance new ways to find tools to help address the human and financial toll of opioid addiction.”

Project submissions will be accepted through September 30, with selected applicants notified in November. Submissions will be evaluated by the FDA’s Center for Devices and Radiological Health, and will be selected based on feasibility, potential public health impact, and novelty of concept. Once selected, successful projects will have the opportunity to closely collaborate with the FDA during development and evaluation of the submitted project, with Breakthrough Device designation automatically awarded to applicable projects.

For further information on the FDA innovation challenge, click here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609188.htm