FDA issues industry challenge to combat opioid epidemic

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The Food and Drug Administration on Wednesday launched a challenge to industry to develop medical devices, including digital health technologies and diagnostic tests, in an effort to combat the nationwide opioid epidemic by targeting the problems of pain, addiction, and diversion.

“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,” said Scott Gottlieb, MD, commissioner of the FDA. “We must advance new ways to find tools to help address the human and financial toll of opioid addiction.”

Gottlieb added that the regulatory agency is “hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis.”

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According to the agency, the FDA’s challenge is open to products regardless of the stage of development as well as developers of currently marketed devices who are interested in demonstrating that their device has an improved benefit-risk profile compared to opioids in the management of pain.

In addition, the FDA is interested in proposals from developers for:

  • Diagnostics to identify patients at increased risk for addiction
  • Treatments for pain that eliminate the need for opioid analgesics (such as opioid-sparing or replacement therapies for acute or chronic pain)
  • Devices or technologies that can prevent diversion of prescription opioids
  • Treatments for opioid use disorder or symptoms of opioid withdrawal

“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,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, which will evaluate submissions from developers. “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.”

Submitted proposals will be evaluated by the agency based on product feasibility, potential public health impact, and novelty of the concept. The FDA will start accepting submissions on June 1, which can be submitted electronically to CDRH-Innovation-Opioid@fda.hhs.gov continuing until September 30—with plans to announce the selected applicants in November.

Additional information about the challenge can be found here.

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