The opioid overdose crisis is a serious and complex challenge facing the United States. The U.S. Food and Drug Administration (FDA), has taken significant steps to decrease unnecessary exposure to opioids, prevent new cases of opioid use disorder (OUD), and support the treatment of people with OUD. The Center for Devices and Radiological Health (CDRH) is committed to helping to end this national crisis.

This draft guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat OUD and used to support marketing submissions. These recommendations are applicable to the design and development of clinical studies to provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD.