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# Opioid Treatment Devices Study Guidance
- URL: https://www.fdaweb.com/opioid-treatment-devices-study-guidance/
- Published: 2024-07-10T12:00:00.000Z
- Updated: 2026-09-14T14:35:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157316

FDA has published a guidance, *Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder*, with recommendations for the design of pivotal studies for devices intended to treat opioid use disorder (OUD) and used to support marketing submissions. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-considerations-studies-devices-intended-treat-opioid-use-disorder?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the recommendations apply to the design and development of clinical studies to provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD.

“The principles discussed in this guidance are intended to assist sponsors and investigators designing studies that can provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD,” the guidance says. “This guidance recommends well-controlled studies for pivotal OUD device studies, but recommendations within this guidance may be applicable to other types of studies intended to generate valid scientific evidence that may be used in providing a reasonable assurance of safety and effectiveness.”

The document says that early feasibility studies and other preliminary studies are outside its scope. Products that are outside the guidance scope are diagnostic tests for the detection of opioid use, devices intended to diagnose or to help determine the risk of developing OUD, devices intended to treat pain, and combination products.