Additional Information
The U.S. Food and Drug Administration (FDA) is announcing two public workshops with the National Institutes of Health (NIH)/National Institute on Drug Abuse (NIDA): “Diagnostic and Monitoring Medical Devices for Opioid Use” (November 7, 2022) and “Risk Prediction Devices of Opioid Use and Opioid Use Disorder – Opportunities and Challenges” (November 8, 2022).
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. During the workshops, patients, caregivers, health care 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 oOUD as well as prevent overdoses.