• Summary
• Background
• Webinar Details
• Webinar Materials

Summary

On June 27, 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 recommendss 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: June 27, 2024

Time: 1:00 PM – 2:00 PM 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/1607111406?pwd=L1ZldHFTNmVZdytucytQZ3Z5WDJNQT09

Passcode: s?V@Q1

Please note: End of
Translation 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)
• International Caller Dial: Please check the international numbers available
• Webinar ID: 160 711 1406
• Passcode: 566540

Webinar Materials

Printable slides for the June 27, 2024 webinar will be available at CDRH Learn under “Postmarket Activities.” sub-section “General Policy.” A few weeks following this webinar, the presentation and transcript will be available on CDRH Learn under “Postmarket Activities,” sub-section “General Policy” as well.

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.