November 7, 2022

The following is attributed to Suzanne Schwartz, M.D., M.B.A., Director of the Office of Strategic Partnerships & Technology Innovation, and William Maisel, M.D., MPH, Director of the Office of Product Evaluation and Quality, of the FDA’s Center for Devices and Radiological Health

Over the next two days, the FDA’s Center for Devices and Radiological Health (CDRH) is partnering with NIH’s National Institute of Drug Abuse (NIDA) to host two connected workshops: “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 two workshops is to promote medical device innovation through discussions with stakeholders about important factors to inform the conduct of clinical studies for diagnosing, monitoring, and managing individuals across the spectrum of opioid use disorder. CDRH hopes the valuable information gleaned from the discussions with patients, caregivers, health care providers, device innovators, researchers, and other stakeholders during this workshop will help drive innovation forward in this important area.

The opioid epidemic is one of the most serious and complex public health crises facing the United States with devastating and far-reaching consequences extending into nearly every community. No single action or group will solve this issue. The increasing number of opioid overdose deaths requires a collaborative and comprehensive approach that includes the rapid development of more effective measures to prevent, diagnose, and treat opioid use disorder (OUD), as well as devices to predict the risk of developing OUD.

To date, CDRH has granted marketing authorization or clearance to several medical devices intended to help individuals who use opioids, and to reduce the risk of opioid-related harm. Additionally, CDRH has a variety of programs and initiatives to spur the development of medical devices, including diagnostic tests and digital health technologies to help combat the opioid crisis and achieve the goal of preventing and treating OUD. We also intend to issue guidance on Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder.

CDRH remains committed to addressing this national crisis by encouraging and fostering the development of innovative medical devices that protect and promote public health and positively impact the lives of individuals using opioids.

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