Food and Drug Administration Releases New Innovation Challenge Seeking Medical Devices to Tackle Opioid Epidemic

Aug 3, 2018

In response to the ongoing opioid epidemic, the Food and Drug Administration (FDA) recently released a new innovation challenge, titled Devices to Prevent and Treat Opioid Use Disorder, seeking medical devices that can help with the prevention and treatment of opioid use disorder. Selected applicants will work directly with the FDA to help expedite the process of getting agency approval for devices aimed at addressing this epidemic. Breakthrough Device designation will be awarded to any applicant devices that meet statutory criteria.

For interested applicants, the challenge is seeking diagnostic or therapeutic medical devices— including mobile apps— that prevent and treat opioid use disorder. Devices at any stage of development are being accepted. Completed submissions must be no longer that 7 pages and include:

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

Completed applications must be submitted on or before September 30. The number of proposals selected will be based on the available resources and quality of submission.
For more information on how to apply, click here: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm609082.htm