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On May 30, 2018, the FDA announced the launch of the Devices to Prevent and Treat Opioid Use Disorder Challenge to spur the development of medical devices, including digital health and diagnostic devices, to help combat the opioid crisis and to help prevent and treat Opioid Use Disorder—a serious health condition which can be a devastating outcome of opioid drug use.

The FDA’s Center for Devices and Radiological Health will accept applications for this challenge from June 1 through September 30, 2018. Medical devices that lead to the prevention and treatment of opioid use disorder are desired and their developers are encouraged to apply. Developers of currently marketed devices who are interested in demonstrating that their device has an improved benefit-risk profile as compared to opioids in the management of pain, may also apply. Applicants accepted into the challenge will receive enhanced communications with FDA review divisions and management during the development of the proposed product. In addition, Breakthrough Device designation will be granted to those devices that meet the statutory criteria for designation without submission of a separate application.

NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.

Target Audience: Medical device developers, medical device manufacturers, software as a medical device developers.

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or [email protected].

If you have any questions about the innovation challenge, please contact [email protected].