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# NPR Questions FDA OK for Opioid Withdrawal Device
- URL: https://www.fdaweb.com/npr-questions-fda-ok-for-opioid-withdrawal-device/
- Published: 2018-05-02T12:00:00.000Z
- Updated: 2026-09-15T00:02:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141349

NPR and Side Effects Public Media say their investigation into Innovative Health Solutions’ Bridge medical device being used for opioid withdrawal found that FDA approved the device indication based on results from a clinical trial that was inaccurately described as a retrospective study. The [report](https://www.npr.org/sections/health-shots/2018/05/02/602908208/questions-raised-about-study-of-device-to-ease-opioid-withdrawal?ref=fdaweb.com) says the device had been approved for use in pain management when the company sought the broader indication.

“Researchers working with Innovative Health Solutions … submitted to a medical journal a study that wasn’t what it appeared to be,” NPR says. “The study authors said it was a ‘retrospective study,’ which means they would have simply reviewed existing medical data. But it seems that they instead conducted a clinical trial that skirted FDA rules and ethical norms, using vulnerable people suffering from addiction as test subjects. FDA then relied on the results of the study in making its decision to clear the Bridge for marketing as a treatment for opioid withdrawal.”

In response to questions from NPR and Side Effects, FDA said it cleared the Bridge for use in opioid withdrawal because the study reported in the 3/2017 *Journal of Drug and Alcohol Abuse* demonstrated “a clinical benefit that outweighs the risk of the device.” The agency told the broadcaster it was reviewing the issues raised by the investigation but gave no indication of what action it might take, if any.

Innovative Health Solutions said that it and the researchers followed FDA rules when the study was conducted. However, NPR reports that such a study would have needed institutional review board oversight and there was none for the Bridge trial.