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FDA launches innovation challenge to combat opioid crisis
In its effort to combat the opioid epidemic, the FDA issued a challenge to encourage the development of innovative medical devices, such as digital health technologies and diagnostic tests, that offer new ways to target addiction, diversion and pain associated with opioids, according to a press release.
Under the new program, the FDA will work closely with companies to accelerate novel product development, according to the release. The FDA will also offer incentives for product developers to invest in products that address opioid addiction, according to the release.
“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,” Scott Gottlieb, MD, commissioner of FDA, said in a press release. “We must advance new ways to find tools to help address the human and financial toll of opioid addiction. For example, better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids.”
The FDA is seeking developers to submit proposals for devices, technologies or diagnostics that are aimed at identifying patients at risk for addiction, preventing diversion and treating pain, opioid use disorder or opioid withdrawal symptoms. Proposed products can be in any stage of development, according to the FDA.
The FDA is accepting submissions from June 1 to Sept. 30. Selected applicants will be announced in November, according to the FDA. Products will be evaluated based on feasibility, potential public health impact and novelty of the concept, according the FDA.
“This new effort builds on the success of previous work to take a collaborative approach to promoting medical device innovation and safety, such as the 2012 challenge that led to multiple new approaches to treat life-threatening, end-stage renal disease,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “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.”
“We also hope that in turn these novel products may also help pave the way for the development of future products that build on the latest technologies,” he added.
Disclosure: Gottlieb and Shuren are employed by the FDA.