FDA Issues Draft Guidance on Devices for Opioid Use Disorder

On July 27, 2023, the United States Food and Drug Administration (FDA) issued a draft guidance titled Clinical Considerations for Studies of Device Intended to Treat Opioid Use Disorder (OUD) as part of its Overdose Prevention Framework. The draft provides an outline for sponsors designing clinical studies for OUD devices.

The FDA’s Overdose Prevention Framework was developed to advance research on evidence-based treatments for substance use disorders (SUD). Perpetuated by deception from pharmaceutical companies, the National Institute on Drug Abuse (NIDA), a subset of the National Institutes of Health (NIH), estimates that the opioid epidemic has contributed to over 106,000 deaths between 1999 and 2021.

NIDA also projects that 21–29% of patients prescribed an opioid for pain management will abuse them. Abuse of prescription opioids and illicit opioid use contributed to 75% of drug overdoses in 2022, according to the CDC.

With a high potential for abuse and extensive prevalence across the US, finding treatment tools is vital for improving public health and mitigating the risks associated with OUD.

“The FDA continues to seek new ways to advance science to address the public health challenges that families and communities across the country face,” said FDA Commissioner Robert M. Califf, MD, in the FDA press release.

“We are committed to helping industry develop solutions that are proven to be effective to address the devastation caused by the overdose crisis. This draft guidance for device studies should prompt industry to collect more comprehensive, timely and diverse data to support device submissions that may help improve the lives of those with opioid use disorder. These and similar efforts will continue to advance within the agency, with the input from industry, stakeholders and, most importantly, those managing opioid use disorder,” he continued.

The guidance covers multiple components of medical devices for OUD. For example, it touches on the challenges of clinical research, including inaccurate drug use reporting, data gaps, treatment durability, and more.

Among the many recommendations provided by the agency, manufacturers and researchers are advised to have a well-defined study population, comprehensive drug use monitoring, bias controls, an adequate follow-up period, retention plans, and data analysis protocols for a robust and well-rounded market submission.

While the document covers multiple aspects of OUD medical devices, it excludes information on diagnostic tests for opioid use, risk detection tools for OUD, and pain management devices.

“Promoting device innovation to assist in the treatment of individuals with opioid use disorder is vital to our ongoing public health response,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the announcement. “This guidance supports innovative approaches for evaluating medical devices that can help combat this national crisis and give patients new tools to treat opioid use disorder, with the assurance that the solutions we need will be driven by robust data.” 

Editor's Note: This article was edited to reflect the correct date of July 27, 2023, instead of January 27, 2023.