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GUIDANCE DOCUMENT

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder Guidance for Industry and Food and Drug Administration Staff July 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2023-D-0466
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.  These recommendations may change as more information becomes available, and the research community gains experience with different designs in relation to OUD device studies.

Submit Comments

Submit Comments Online

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:

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.

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