- September 14, 2023
- 1:00 PM - 2:00 PM ET
On September 14, 2023, the U.S. Food and Drug Administration (FDA) held a webinar for industry and other interested stakeholders to discuss the draft guidance: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder.
During this webinar, the FDA:
- Discussed the scope and purpose of the draft guidance;
- Discussed the challenges in designing studies of devices intended to treat OUD;
- Discussed the important design features to consider for OUD device studies; and
- Answered questions about the draft guidance.
The opioid overdose crisis is a serious and complex challenge facing the United States. The U.S. Food and Drug Administration (FDA), including the Center for Devices and Radiological Health, has taken significant steps to decrease unnecessary exposure to opioids, prevent new cases of opioid use disorder (OUD), and support the treatment of people with OUD.
The Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder draft guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat OUD and used to support marketing submissions. OUD device studies designed using the recommendations set out in this guidance may advance the treatment of OUD by providing scientific evidence that aids FDA in determining whether there is a reasonable assurance that a device intended to treat OUD is safe and effective.
The presentation, printable slides, and transcript are available at CDRH Learn under "Specialty Technical Topics," sub-section "Neurological Devices."
Submit public comments to the draft guidance under docket number FDA-2023-D-0466 at www.regulations.gov by October 26, 2023, to ensure that the FDA considers comments on this draft guidance before it begins work on the final guidance.