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FDA Calls for Innovative Technologies to Treat Opioid Use Disorder

May 31, 2018
Agency to work closely with companies on accelerated development

A PPM Brief

FDA recently announced1 that it will be launching an “innovation challenge” for the development of medical devices, such as mHealth technologies, diagnostics, and opioid-sparing or replacement therapies, that could provide solutions to detecting, treating and preventing opioid addiction, addressing diversion and treating pain.

Open to products in any stage of development from concept to testing, FDA will accept submissions from June 1, 2018, through September 30, 2018, and intends to announce the selected applicants in November of this year. Submissions will be evaluated by FDA’s Center for Devices and Radiological Health based on product feasibility, potential public health impact, and novelty of concept.1

“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,” said FDA Commissioner Scott Gottlieb, MD.

The challenge also applies to developers of marketed devices to demonstrate how their device has an improved benefit-risk profile as compared to opioids in the management of pain. Products selected will have the opportunity to work closely with the agency to accelerate the development and review of their products, providing additional incentives for product developers to invest in products that can address aspects of the addiction crisis, and advance the development of promising technologies.1 Accepted developers may also receive Breakthrough Device designation if certain criteria is met.

“This new effort builds on the success of previous work to take a collaborative approach to promoting medical device innovation and safety,” said Jeff Shuren, MD, director of the FDA Center for Devices and Radiological Health. “The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder.”

Last updated on: June 1, 2018
Continue Reading:
A Brief History of the FDA’s Role in the Ongoing Effort to Ensure Safe Opioid Use
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