- Docket Number:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
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This draft guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat OUD and used to support marketing submissions.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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2023-D-0466.