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FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder

The application period for the FDA Innovation Challenge has ended. Applications selected for the challenge will be announced in November 2018. If you applied to the challenge, read below for information on what to expect next.

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Background on the Challenge

The opioid epidemic is one of the most profound public health crises facing the United States and the current crisis of opioid overdose deaths requires innovative approaches. The agency has already taken significant steps to decrease public exposure to opioids, prevent new cases of opioid use disorder—also known as opioid addiction—and support the treatment of those with the disorder. The FDA remains committed to addressing this national crisis on all fronts, with a focus on encouraging medical product innovation to prevent new cases of opioid abuse and addiction and to treat those addicted. As part of important efforts to address the epidemic of opioid misuse and abuse, the FDA launched an innovation challenge on May 31, 2018, to spur the development of medical devices, including diagnostic tests and digital health technologies (mobile medical applications) to help combat the opioid crisis and achieve the goal of preventing and treating opioid use disorder.

The application period for the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder (“the Challenge”) was open from June 1, 2018, through September 30, 2018. Opioid use disorder is a serious health condition that can cause significant physical, emotional, and cognitive impairment. The disorder can arise as an unintended consequence of routine medical care, abuse of prescription opioid pain medications and the use of illicit opioid drugs. Opioid use disorder affects more than 2 million Americans1, disproportionately impacts minority populations, and is increasing among people ages 45 to 64. Through this Challenge, the FDA aims to promote and expedite the development of innovative medical devices to help prevent opioid use disorder from happening at all.

Image of FDA Innovation Challenge - a group of people looking at data

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Criteria for Challenge Application Review

The Challenge was intended for diagnostic or therapeutic medical devices, including mobile medical apps, that address the opioid epidemic by preventing and treating opioid use disorder (opioid addiction). Potential examples of medical devices that may address this problem include, but are not limited to, diagnostic devices that identify patients at increased risk for addiction, opioid-sparing or -replacement therapies for acute or chronic pain, and devices that monitor the use and prevent diversion of prescription opioids.

Challenge applicants were asked to describe in their proposals:

  • 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 other available alternatives

Medical devices at any stage of development were eligible for the Challenge. Feasibility and the potential impact of FDA participation in development to expedite marketing of the device are other factors that will be considered during application review.

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What Happens Next in the Challenge?

Proposals that were submitted for the Challenge by September 30, 2018, will be evaluated. The number of proposals selected into the Challenge will be determined by the quality of applications received and available FDA resources.

The FDA will notify medical device developers whose applications are selected for the Challenge directly. Applicants will be notified of their application status with the following possible outcomes:

  • NOT ACCEPTED: CDRH will contact applicants whose submissions are not accepted into the Challenge. Applications not accepted for the Challenge can still participate in all the existing regulatory programs at CDRH, including Breakthrough Device designation.
  • ACCEPTED: CDRH will contact applicants whose submissions are selected into the Challenge to schedule a teleconference with the appropriate review division.

The agency intends to issue a public announcement about applications selected into the Challenge in November and will obtain consent from device developers before publicly disclosing any proprietary information from their application.

Applicants selected for the Challenge will work directly with the FDA to accelerate the development of and eventual review of marketing applications for innovative products, similar to what occurs under the Breakthrough Devices Program. In addition, Breakthrough Device designation will be granted to those devices that meet the statutory criteria for designation without submission of a separate application.

If selected into the Challenge, the process will begin with the collaboration phase, an agreed-upon period of interaction (not to exceed 90-days) the goals of which will be: 1) to create a mutual understanding of the medical device, the patient and user needs, the important risks and benefits; and 2) to establish the regulatory pathway forward.

FDA review divisions and management will work closely with developers of devices accepted into the Challenge. In most cases, applicants will eventually submit one or more formal applications to the FDA, such as an Investigational Device Exemption (IDE), De Novo, 510(k), or Premarket Approval (PMA). The review of each of these applications will be expedited to minimize review times. The regulatory standard of demonstration of reasonable assurance of safety and effectiveness still applies.

1 Source: 2016 National Survey on Drug Use and Health

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Page Last Updated: 10/01/2018
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