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# Guide on Devices Opioid Use Disorder
- URL: https://www.fdaweb.com/guide-on-devices-opioid-use-disorder/
- Published: 2023-07-28T12:00:00.000Z
- Updated: 2026-09-14T18:46:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154982

*Federal Register* notice: FDA is making available a draft guidance entitled “Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder.” The document provides recommendations on designing pivotal clinical studies for such devices to support their marketing submissions. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-07-28/pdf/2023-15968.pdf?ref=fdaweb.com).