FDA Announces Innovation Challenge for Devices to Prevent and Treat Opioid Use Disorder

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

According to the announcement, diagnostic and therapeutic devices at any stage of development are eligible for submission to the Challenge.  The FDA also indicates that currently marketed devices may be submitted if developers are interested in demonstrating that 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 that they 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 also 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.

Jordan Gottdank
Jordan Gottdank is an associate in our San Diego office. His practice focuses on patent prosecution and litigation. Mr. Gottdank earned his J.D. from UCLA School of Law, where he co-founded the Intellectual Property Law Association and worked as a research assistant in the fields of intellectual property law and international environmental regulation. While in law school, Mr. Gottdank served as a judicial extern for four judges in the U.S. District Court for the Central District of California, working exclusively on patent cases. He has experience in a wide range of fields, including electronics, communications technology, optics, medical devices, transportation, apparel, and sporting goods. Mr. Gottdank worked as a summer associate at the firm in 2014 and joined the firm in 2015.
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