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  4. Webinar - Quality Management System Regulation: Key Takeaways - 12/16/2025
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Webcast | Virtual

Event Title
Webinar - Quality Management System Regulation: Key Takeaways
December 16, 2025

Date:
December 16, 2025
Time:
1:00 p.m. - 2:00 p.m. ET

Summary

The U.S. Food and Drug Administration (FDA) held a webinar for industry and other interested parties to discuss the Quality Management System Regulation (QMSR). The FDA highlighted key takeaways of the QMSR and addressed frequently asked questions regarding this topic.  

Background

The Medical Devices Quality System Regulation Amendments final rule was published on February 2, 2024, with an effective date of February 2, 2026.

The final rule amends the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices.

This action continues the FDA’s efforts to align its regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.

Webinar Prerequisite Materials

Please review the following learning modules in advance of attending the webinar: 

Event Materials

The presentation, printable slides, and transcript will be available on this webpage and at CDRH Learn under “Postmarket Activities,” sub-section “Quality Management System Regulation.”

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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