Webcast | Virtual
Event Title
Webinar – Final Guidance: Remanufacturing of Medical Devices
September 10, 2024
- Date:
- September 10, 2024
- Time:
- 1:00 PM - 2:00 PM ET
Summary
On September 10, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar to discuss the final guidance: Remanufacturing of Medical Devices.
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Background
The purpose of this guidance is to clarify the distinction between servicing and remanufacturing of medical devices. Entities performing these activities have different regulatory responsibilities. This clarification will help ensure consistency and better understanding of the regulatory requirements applicable to remanufacturers. Additionally, the guidance recommends information to be included in the labeling of reusable medical devices to ensure their continued quality and safety during servicing. The FDA developed this guidance by considering factual evidence and insights from its activities, aiming to provide clear policy for stakeholders in this field.
Webinar Details
Registration is not necessary.
Date: September 10, 2024
Time: 1:00 p.m. - 2:00 p.m. EST
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/1601735374?pwd=Njd5YVY2R2tuTnU0Y00rcS9sNTYyZz09
Passcode: q7N#jd
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)
- +1 646 828 7666 US (New York)
- +1 646 964 1167 US (US Spanish Line)
- +1 415 449 4000 US (US Spanish Line)
- +1 551 285 1373 US
- +1 669 216 1590 US (San Jose)
- For higher quality, dial a number based on your current location:
- International Caller Dial: Please check the international numbers available
- Webinar ID: 160 173 5374
- Passcode: 736452
Webinar Materials
The presentation, printable slides, and transcript will be available on this webpage and at CDRH Learn under “Postmarket Activities”, sub-section “General Policy.”
If you have questions about this guidance document, please contact CDRH’s Regulation, Policy, and Guidance Staff at RPG@fda.hhs.gov. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.