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  4. Webinar - Final Guidance: Remanufacturing of Medical Devices - 09/10/2024
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Webcast | Virtual

Event Title
Webinar - Final Guidance: Remanufacturing of Medical Devices
September 10, 2024

Date:
September 10, 2024
Time:
1:00 p.m. - 2:00 p.m. ET

Summary

On September 10, 2024, the U.S. Food and Drug Administration (FDA) held a webinar to discuss the final guidance: Remanufacturing of Medical Devices.

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 Materials

The presentation, printable slides, and transcript are available on 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.

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