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Workshop | In Person

Event Title
Joint Public Workshops - Medical Devices for Opioid Use
November 7 - 8, 2022

Date:
November 7 - 8, 2022
Day1:
- ET
Day2:
- ET
  • Day 1 - November 7, 2022:  Diagnostic and Monitoring Medical Devices for Opioid Use 
  • Day 2 - November 8, 2022:  Risk Prediction Devices of Opioid Use and Opioid Use Disorder - Opportunities and Challenges 

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. 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

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

https://fda.yorkcast.com/webcast/Play/ab36a900e9394e059b5b3221ae91750c1d

AGENDA

Risk Prediction Devices of Opioid Use and Opioid Use Disorder: Opportunities and Challenges
Time Title Role Participant (Specialty) Institution
November 8, 2022 (Webcast by FDA Studio)
  Emcee Physician, OPEQ IO Jacqueline Cunkelman, MD, MPH   Food and Drug Administration
  Emcee Physician, OPEQ IO Jisun Yi, MD   Food and Drug Administration
10:00 A.M. FDA Opening Remarks Director, OPEQ William Maisel, MD, MPH   Food and Drug Administration
10:10 A.M. NIH Opening Remarks Branch Chief, 
Genetics, Epigenetics and Developmental Neuroscience		 Jonathan Pollock, PhD   National Institutes of Health
10:20 A.M. Current Landscape of Predicting Risk of Developing Opioid Use Disorder (OUD) Branch Chief, 
Genetics, Epigenetics and Developmental Neuroscience		 Jonathan Pollock, PhD Geneticist and Neuroscientist National Institutes of Health
Applying an Evidence-Based Regulatory Framework Assistant Director, Toxicology Joseph Kotarek, PhD Biologist Food and Drug Administration
10:50 A.M. Session 1: Novel Approaches and Study Design Considerations for Devices to Predict Risk of OUD Moderator Ken Skodacek CDRH Deputy Ombudsman Food and Drug Administration
Moderator Jonathan Pollock, PhD Branch Chief,
Genetics, Epigenetics and Developmental Neuroscience		 National Institutes of Health
10:50 A.M. Genetic Predictors and OUD Speaker Joel Gelernter, MD Professor (Psychiatry, Genetics and Neurobiology) and Director (Division of Human Genetics) Yale University School of Medicine
11:00 A.M. Metabolomics and OUD Speaker Susan Sumner, PhD Professor (Department of Nutrition) University of North Carolina (Nutrition Institute)
11:10 A.M. Challenges in Clinical Study Design and Conduct Speaker Laura Beirut, MD Alumni Endowed Professor of Psychiatry,
Leader of Precision Medicine Function		 Washington University School of Medicine in St. Louis
11:20 A.M. Potential Bias, Uncertainty & Faulty Prediction – Challenges in Artificial Intelligence / Machine Learning Algorithm Development and Use Speaker Alex Hatoum, PhD Research Assistant Professor Washington University in St. Louis
11:30 A.M. Ethical Considerations for OUD Prediction Speaker Travis Rieder, PhD Associate Research Professor and Director of the Master of Bioethics Program Johns Hopkins Berman Institute of Bioethics
11:40 A.M. Digital Health Technologies and Predicting Risk of OUD  Speaker Kelly Clark, MD, MBA President, Addiction Crisis Solutions Addiction Crisis Solutions
11:50 A.M. Question & Answer Moderator Ken Skodacek CDRH Deputy Ombudsman Food and Drug Administration
Moderator Jonathan Pollock, PhD Branch Chief, 
Genetics, Epigenetics and Developmental Neuroscience		 National Institutes of Health
12:05 P.M. Break
12:15 P.M.

Multistakeholder Panel Discussion

(Session 1: Novel Approaches and Study Design Considerations for Devices to Predict Risk of OUD)

 Moderator Ken Skodacek CDRH Deputy Ombudsman Food and Drug Administration
Moderator Jonathan Pollock, PhD Branch Chief,
Genetics, Epigenetics and Developmental Neuroscience		 National Institutes of Health
Panelist Joel Gelernter, MD Professor (Psychiatry, Genetics and Neurobiology) and Director (Division of Human Genetics) Yale University School of Medicine
Panelist Susan Sumner, PhD Professor (Department of Nutrition) University of North Carolina (Nutrition Institute)
Panelist Laura Beirut, MD

Alumni Endowed Professor of Psychiatry,

Leader of Precision Medicine Function    

 Washington University School of Medicine in St. Louis
Panelist Alexander Hatoum, PhD Research Assistant Professor Washington University in St. Louis
Panelist Travis Rieder, PhD Associate Research Professor and Director of the Master of Bioethics Program Johns Hopkins Berman Institute of Bioethics
Panelist Kelly Clark, MD, MBA President, Addiction Crisis Solutions Addiction Crisis Solutions
Panelist Bilal Muhsin Chief Operating Officer     Masimo Corporation
Panelist Keegan Wicks National Advocacy and Outreach Manager Faces and Voices of Recovery (FAVOR)
1:00 P.M. Lunch Break
1:45 P.M. Session 2: Devices to Predict Risk of Opioid Use Disorder (OUD) – Opportunities and Challenges of Implementation Moderator Courtney Lias, PhD OHT3 Director Food and Drug Administration
Moderator Jonathan Pollock, PhD Branch Chief, 
Genetics, Epigenetics and Developmental Neuroscience		 National Institutes of Health
1:45 P.M. Potential Opportunities for Integrating Predictive Devices for OUD into Clinical Care Paradigms Speaker Keri Donaldson, MD Founder and CEO SOLVD Health
2:00 P.M. Challenges and Other Considerations Associated with Use of Devices that Predict Risk of OUD Development Speaker Laura Bierut, MD

Alumni Endowed Professor of Psychiatry,


Leader of Precision Medicine Function

 Washington University School of Medicine in St. Louis
2:15 P.M. Question & Answer Moderator Courtney Lias, PhD OHT3 Director Food and Drug Administration
Moderator Jonathan Pollock, PhD Branch Chief, 
Genetics, Epigenetics and Developmental Neuroscience		 National Institutes of Health
2:30 P.M. Break
2:45 P.M.

Multistakeholder Panel Discussion

(Session 2: Devices to Predict Risk of Opioid Use Disorder (OUD) – Opportunities and Challenges of Implementation)

 Moderator Courtney Lias, PhD OHT3 Director Food and Drug Administration
Moderator Jonathan Pollock, PhD Branch Chief, 
Genetics, Epigenetics and Developmental Neuroscience		 National Institutes of Health
Panelist Keri Donaldson, MD Founder and Chief Executive Officer SOLVD Health
Panelist Laura Beirut, MD

Alumni Endowed Professor of Psychiatry,

Leader of Precision Medicine Function

 Washington University School of Medicine in St. Louis
Panelist Kirsten Tullia, JD, MPH Vice President
Payment and Healthcare Delivery Policy		 Advanced Medical Technology Association (AdvaMed)
Panelist Travis Rieder, PhD Associate Research Professor and Director of the Master of Bioethics Program Johns Hopkins Berman Institute of Bioethics
Panelist Daniel Jacobson, PhD Computational Systems Biologist Oak Ridge National Laboratory
Panelist Kathy Sapp Chief Executive Officer American Chronic Pain Association
Panelist Jessica Hulsey Founder and Executive Director Addiction Policy Forum
Panelist Keegan Wicks National Advocacy and Outreach Manager Faces and Voices of Recovery
3:30 P.M. NIH Closing Remarks Branch Chief, 
Genetics, Epigenetics and Developmental Neuroscience		 Jonathan Pollock, PhD   National Institutes of Health
FDA Closing Remarks Director, OPEQ William Maisel, MD, MPH   Food and Drug Administration

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

Biosketches

Participant biosketches (PDF 1.2MB)

Registration

Online registration is now closed. The link to view the webcast is posted under the Webcast portion of this web announcement.

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

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

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