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SUMMARY

The U.S. Food and Drug Administration (FDA) is announcing two connected public workshops with the National Institutes of Health (NIH) “Diagnostic and Monitoring Medical Devices for Opioid Use” and “Risk Prediction Devices of Opioid Use and Opioid Use Disorder – Opportunities and Challenges.” The purpose of these workshops is to promote medical device innovation through discussions with stakeholders about important factors to inform the conduct of clinical studies for medical devices to diagnose, monitor, and manage individuals across the spectrum of opioid use, with a goal to foster the safe use of opioids. Patients, caregivers, healthcare providers and other stakeholders will share their perspectives on using opioids, living with opioid use disorder (OUD),  and important features of clinical studies for novel devices designed to predict, diagnose, and monitor opioid use disorder as well as prevent overdoses.

BACKGROUND

The opioid epidemic is one of the most serious and complex public health problems facing the United States with devastating and far-reaching consequences extending into nearly every community.¹  Advancing efforts to mitigate the opioid crisis is one of the top priorities for the FDA and the NIH. The increasing number of opioid overdose deaths requires rapid development of more effective measures to prevent, diagnose, and treat OUD, as well as devices to predict the risk of developing OUD.^2,3 

The FDA’s Center for Devices and Radiological Health (CDRH) and NIH’s National Institute on Drug Abuse (NIDA) remain committed to addressing this national crisis by encouraging and fostering the development of innovative medical devices that protect and promote public health, positively impacting the lives of individuals using opioids.   

The aims of these two workshops are:

• To obtain patients’ perspectives on opioid use and OUD and the impact on their daily lives; 
• To provide a forum for device manufacturers and researchers to discuss challenges they may encounter along the total product life cycle (TPLC) of medical devices related to opioid use;
• To promote medical device innovation by fostering necessary and productive discussions amongst stakeholders who provide services to people experiencing OUD, develop medical devices and research interventions for the prediction, prevention and diagnosis of OUD as well as monitoring in people using opioids; and 
• To foster informative discussions around health equity, perceived stigma, and digital inequalities that affect people using opioids or living with OUD.  

The November 7, 2022 workshop "Diagnostic and Monitoring Medical Devices for Opioid Use" will focus on topics related to development, commercialization, and adoption of monitoring and diagnostic devices indicated for patients using opioids. The November 8, 2022 virtual workshop "Risk Prediction Devices of Opioid Use and Opioid Use Disorder: Opportunities and Challenges" will focus on opportunities and challenges related to the development, commercialization, and adoption of devices indicated to predict the risk of developing OUD.  

The FDA intends to provide background materials at least 48 hours in advance of these workshops to facilitate discussion at these workshops. This background material will not serve as guidance and is not intended to propose or implement policy changes.

• Date, Time and Location
• Webcast
• Preliminary Agenda
• Registration
• Comments
• Contact 

DATE, TIME, and LOCATION

November 7, 2022 workshop led by NIH

The November 8, 2022 virtual workshop led by the FDA will be available via webcast from 10:00 a.m. until 4:30 p.m., ET.

WEBCAST

The November 8, 2022 virtual public workshop will be webcast by the FDA, and the link will be provided in your confirmation email if you register to view the webcast. The link for the archived webcast will be posted to the webpage for viewing after the workshop.

 

PRELIMINARY AGENDA

November 8, 2022

Risk Prediction Devices of Opioid Use and Opioid Use Disorder: Opportunities and Challenges

Start Time	End Time	Topic
10:00 am	10:20 am	Opening Remarks
10:20 am	10:50 am	Current Landscape of Predicting Risk of Developing Opioid Use Disorder (OUD) Applying an Evidence-Based Regulatory Framework
10:50 am	12:45 pm	Session 1: Novel Approaches and Study Design Considerations for Devices to Predict Risk of OUD Genetic Predictors and OUD Proteonomics and OUD Challenges in Clinical Study Design & Conduct Potential Bias, Uncertainty & Faulty Prediction - Challenges in Artificial Intelligence/Machine Learning Algorithm Development and Use Ethical Considerations for OUD Prediction Digital Health Technologies and Predicting Risk of OUD Q&A Panel Discussion
12:45 pm	1:45 pm	Lunch
1:45 pm	3:30 pm	Session 2: Devices to Predict Risk of Opioid Use Disorder (OUD) – Opportunities and Challenges of Implementation Potential Opportunities for Integrating Predictive Devices for OUD into Clinical Care Paradigms Challenges and Other Considerations Associated with Use of Devices that Predict of OUD Development Q&A Panel Discussion
3:30 pm	4:00 pm	Closing Remarks

Please refer to the linked website under Date, Time, and Location for the agenda for the November 7, 2022 workshop.

Registration

If you wish to also register for the November 7th public workshop "Diagnostic and Monitoring Medical Devices for Opioid Use,” you must register with NIH.

If you wish to register for the November 8, 2022 virtual public workshop “Risk Prediction Devices of Opioid Use and Opioid Use Disorder: Opportunities and Challenges”, you must register by 4:00 p.m. by November 7, 2022. There is no fee to register for the public workshop and registration will be on a first-come, first-served basis. When registering, you will be asked to provide the following information:

1. First Name
2. Last Name 
3. Affiliation, Company, or Organization
4. Stakeholder category (Academia, Clinician, Consultant, Government, Industry, Press, Regulatory, and Other)
5. Email address 
6. Telephone number

Registrants will receive confirmation when requests for participation have been accepted. 

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov by October 14, 2022.

COMMENTS

Comments regarding the workshop should be submitted to https://www.regulations.gov/, Docket No. FDA-2022-N-2393 by December 7, 2022.

Please refer to the Instructions for Submitting Comments available in the Docket to ensure that your feedback is received.  

CONTACT

For questions regarding workshop content please contact:

Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
opioid_device_workshop@fda.hhs.gov

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1 FDA In Brief: FDA Hosts Third Summit Focused on Reducing the Availability of Opioids Online | FDA

2 Commonly Used Terms | CDC's Response to the Opioid Overdose Epidemic | CDC

3 Prevent Opioid Abuse and Addiction | HHS.gov