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

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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.

List of Applicants Selected for the Challenge

The FDA received an overwhelming response to the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder. Over 250 applications were received from medical device developers large and small. After careful review using an established set of criteria, eight challenge participants have been selected. The medical devices from the selected participants include those intended to predict the risk of opioid used disorder (OUD), detect opioid overdose, dispense medication and provide pain treatment alternatives to opioids.


Product Name


Algomet Rx, Inc.

Rapid Drug Screen



Withheld Per Company Request


Brainsway, Ltd

Brainsway Deep Transcranial Magnetic Stimulation (DTMS) Device

Opioid Use Disorder Therapy

CognifiSense, Inc.

Virtual Reality Neuropsychological Therapy (VRNT)

Pain Therapy

iPill Dispenser

iPill Dispenser

Medication Dispensing

Masimo Corporation

SafetyNet Opioid System

Overdose Therapy


Opioid Prediction Service


ThermoTek, Inc.

NanoThermTM and VascuThermTM Systems

Pain Therapy

What Happens Next?

Applicants selected for the Challenge will work directly with the FDA to accelerate the development and expedite marketing application review of 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.

The process will begin with the collaboration phase starting within 90 days of the announcement, the goals of which will be: 1) to create a mutual understanding of the target product profile for the medical device including the patient and user needs and the important risks and benefits; and 2) to discuss the potential regulatory pathways going 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, De Novo, 510(k), or Premarket Approval. The review of each of these applications will be expedited to minimize review times. The regulatory standard of demonstrating a reasonable assurance of safety and effectiveness still applies.

For applicants who were not selected the standard mechanisms for interaction with the FDA’s Center for Devices and Radiological Health (CDRH) are available. These sponsors have been encouraged to interact with the agency through the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov. DICE will assist in answering questions on U.S. medical device regulation or to direct sponsors to the appropriate premarket review division.

Background on the Challenge

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 a group of people viewing paper posted on a screen.

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.

1 Source: 2016 National Survey on Drug Use and Health


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