Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder." Design of clinical studies for devices intended to treat opioid use disorder (OUD) is challenging. This guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat opioid use disorder ("OUD device studies") 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. This draft guidance is not final nor is it for implementation at this time.