The Food and Drug Administration (FDA) announced a medical device innovation challenge to help address opioid abuse and misuse. The FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder intends to encourage development of medical devices to combat the ongoing opioid crisis.

According to the announcement, diagnostic and therapeutic devices at any stage of development are eligible for submission. The FDA also indicates that currently marketed devices may be submitted if developers are interested in demonstrating their device has an improved benefit-risk profile as compared to opioids in the management of pain. Non-limiting examples of suitable medical devices provided by the FDA include diagnostic devices that identify patients at increased risk for addiction, opioid-sparing or opioid-replacement therapies for acute or chronic pain, and devices that monitor the use and prevent diversion of prescription opioids.

According to the announcement, Challenge submissions should describe:

  • The novelty of the medical device/concept,
  • The development plan for the medical device,
  • The development team, and
  • The anticipated benefit of the device used by patients and the impact on public health as compared to other available alternatives.

The FDA has indicated it will work directly with selected applicants during a collaboration phase to accelerate the development and review of new devices, similar to the process under the existing Breakthrough Devices Program. The announcement reports that selected devices will also be granted Breakthrough Device designation without requiring a separate application. Challenge applications will be accepted through September 30, 2018. The FDA will be hosting a webinar on July 25, 2018 to provide further information.