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# Opioid Disorder Innovative Devices
- URL: https://www.fdaweb.com/opioid-disorder-innovative-devices/
- Published: 2023-07-27T12:00:00.000Z
- Updated: 2026-09-14T18:46:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154967

FDA has published a draft guidance, *Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder*, with recommendations for designing pivotal clinical studies of medical devices intended to treat opioid use disorder and used to support marketing submissions. The [document](https://www.fda.gov/media/170561/download?ref=fdaweb.com)’s 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 opioid use disorder, FDA says.

The recommendations also may be useful for evaluating other types of valid scientific evidence demonstrating clinically significant results that may be used to provide a reasonable assurance of safety and effectiveness, it says.

An online [statement](https://content.govdelivery.com/accounts/USFDA/bulletins/367866c?ref=fdaweb.com) issued with the guidance says its recommendations “address some of the complex challenges associated with these studies, including inaccurate participant reports of drug use, high rates of missing data, the confounding effects of concomitant drug treatments, and the need to demonstrate the durability of the device’s treatment effect, which can necessitate prolonged observation.”

The guidance recommends that pivotal studies should have a well-defined study population, appropriately monitor drug use, control for bias, and include an appropriate follow-up period, the statement says. “By addressing these challenges early in the development of their clinical studies,” it concludes, “sponsors should be well-positioned to obtain the most useful data to provide a reasonable assurance of safety and effectiveness….”