The opioid epidemic is a serious and complex public health emergency facing the United States. The Agency has already taken significant steps to decrease public exposure to opioids, prevent new cases of opioid use disorder (OUD) and support the treatment of those with the disorder. The Center for Devices and Radiological Health (CDRH) is committed to helping to end this national crisis.
This guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat opioid use disorder (hereafter “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. OUD device studies designed using the recommendations set out in this guidance may advance the treatment of OUD by providing scientific evidence that aids FDA in determining whether there is a reasonable assurance that a device intended to treat OUD is safe and effective…
