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GUIDANCE DOCUMENT

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder Draft Guidance for Industry and Food and Drug Administration Staff July 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
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

Docket Number:
FDA-2023-D-0466
Issued by:
Guidance Issuing Office
Center 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This draft guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat OUD and used to support marketing submissions.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.

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