Welcome
RECORDING
Below is Day 1 Workshop recording.
Recording - Day 1: November 7, 2022
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 Disorders: 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.
ADDITIONAL WORKSHOP BACKGROUND MATERIALS (FDA MATERIALS)
