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  5. Webinar – Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder – Draft Guidance - 09/14/2023
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar – Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder – Draft Guidance
September 14, 2023

Date:
September 14, 2023
Time:
1:00 PM - 2:00 PM ET

Summary

On September 14, 2023, the U.S. Food and Drug Administration (FDA) will host a webinar for industry and other interested stakeholders to discuss the draft guidance: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder.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 will:

  • Discuss the scope and purpose of the draft guidance;
  • Discuss the challenges in designing studies of devices intended to treat OUD; 
  • Discuss the important design features to consider for OUD device studies; and
  • Answer questions about the draft guidance.

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Background

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The Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder draft guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat OUD and used to support marketing submissions.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.

Webinar Details

Registration is not necessary.

Date: September 14, 2023

Time: 1:00 PM - 2:00 PM ET

Please dial in 15 minutes before the start of the call to allow time to connect.

Please click the link below to join the webinar:
https://fda.zoomgov.com/j/1607297163?pwd=NHJ2Q0ozdFpUdzJSYzVBSTVTek81QT09  

Passcode: LA@M7i

Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining the webinar by phone only.

  • U.S. Callers Dial: 833-568-8864 (Toll Free)
    • For higher quality, dial a number based on your current location:
      • +1 669 254 5252 US (San Jose)
      • +1 646 964 1167 US (US Spanish Line)
      • +1 646 828 7666 US (New York)
      • +1 551 285 1373 US
      • +1 669 216 1590 US (San Jose)
      • +1 415 449 4000 US (US Spanish Line)
  • International Caller Dial: Please check the international numbers available 
  • Webinar ID: 160 729 7163
  • Passcode: 772170

Webinar Materials

After the webinar, the presentation, printable slides, and transcript will be available at CDRH Learn under "How to Study and Market Your Device," sub-section " Clinical Studies/Investigational Device Exemption (IDE)."

Comments

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.

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