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July 25, 2018
FDA Innovation Challenge: 

Devices to Prevent and Treat Opioid Use Disorder

Jonathan Jarow, M.D.

Chief Medical Officer

Office of Device Evaluation

Michelle Tarver, M.D., PhD

Director, Patient Science & Engagement Program

Office of the Center Director

Center for Devices and Radiological Health
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• The Opioid Epidemic

• FDA’s Efforts to Combat the Opioid Crisis

• Overview of the Innovation Challenge

• Tips for Potential Applicants

• Resources 

• Questions

Agenda
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The Opioid Crisis: FDA’s Priorities & Strategies

 Appropriate Dose/Duration Labeling

Appropriate Packaging, Storage, and Disposal

 Health Care Provider Education

Naloxone

Medication Assisted Treatment (MAT)

1. Decreasing Exposure & Prevent New Addiction

2. Supporting the Treatment of Those With Opioid Use Disorder

3. Fostering the Development of Novel Pain Treatment Therapies

 Partnerships & Meetings

 Abuse Deterrent Formulations (ADFs)

 Pain Treatment Alternatives

4. Improving Enforcement & Assessing Benefit-Risk

Improving Enforcement

Assessing Benefit-Risk 
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• In the past few years, FDA has cleared, granted, or 

approved more than 200 devices related to the treatment 

or management of pain

• Includes 10 with new or novel technologies, such as brain 

and spinal cord stimulators to relieve pain and reduce the 

need for opioid drugs to patients suffering from either acute 

or chronic pain

• The FDA also recently granted a new indication to an 

electric stimulation device for use in helping to reduce the 

symptoms of opioid withdrawal

FDA’s Efforts to Combat

The Opioid Crisis
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Overview of the Innovation Challenge

Challenge Goals:

• Innovative and creative approaches to the use of medical 

devices in combatting the U.S. opioid crisis

• Development of non-opioid treatments for acute and 

chronic pain

• Expedited development and review of innovative, safe and 

effective medical devices to help prevent and treat opioid 

use disorder
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Overview of the Innovation Challenge

Eligibility

• Any medical device that prevents or treats opioid use disorder, 

including:

o Diagnostic Devices

o Therapeutic Devices

o Digital Health Technologies (e.g., mobile medical apps)

o Combination Products: primary mode of action is by the device

• Medical devices at any stage of development are eligible

• U.S.-based and foreign applicants are eligible to apply

• Per federal law, foreign firms will need a U.S. representative to market 

a device in the U.S.
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Overview of the Innovation Challenge

Challenge Submissions Should Describe:

• Intended use

• Novelty of the medical device/concept 

• Development plan for the medical device 

• Development team 

• Anticipated benefit of the device 

• Impact on public health as compared to other available 

alternatives
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Overview of the Innovation Challenge

Other Factors the FDA will Consider:

• Feasibility of device/concept

• Potential impact of FDA participation in 

development
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Challenge Timeline

• Applications must be submitted electronically to FDA by 

September 30, 2018, through the dedicated mailbox: 

CDRH-Innovation-Opioid@fda.hhs.gov 

• We intend to announce applications selected for the 

challenge in November 2018

Overview of the Innovation Challenge
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What to Expect If Your Application is Selected:

• Development Phase 

• Premarket Application 

• Expedited Premarket Review

Overview of the Innovation Challenge
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• You may submit multiple applications if you have 

more than one eligible device

• FDA will not review device applications prior to 

submission deadline or provide specific advice to 

challenge applicants. If your device/concept meets 

the challenge criteria, please submit an 

application.

• There is no official application form. The 

application format is outlined on the challenge 

website. 

Tips for Potential Applicants
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• Devices to Prevent and Treat Opioid Use Disorder Innovation 

Challenge Webpage (includes application format)

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProducts

andTobacco/CDRH/CDRHInnovation/ucm609082.htm

• Device Advice: Comprehensive Regulatory Assistance

https://www.fda.gov/medicaldevices/deviceregulationandguidance/

• Mobile Medical Applications Webpage

https://www.fda.gov/medicaldevices/deviceregulationandguidance/

• Breakthrough Devices Webpage

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/H

owtoMarketYourDevice/ucm441467.htm

Resources
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Questions? 

About the Innovation Challenge:

CDRH-Innovation-Opioid@fda.hhs.gov 

About Medical Device Regulation:

Division of Industry and Consumer Education 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will be 

available by August 2, http://www.fda.gov/training/cdrhlearn

Under the Heading: Specialty Technical topics; Subheading: 

Neurological Device 

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