Town Hall | Virtual
Event Title
Town Hall – Quality Management System Regulation: Risk and Design and Development
January 14, 2026
- Date:
- January 14, 2026
- Time:
- 2:00 p.m. - 3:00 p.m. ET
Summary
The U.S. Food and Drug Administration (FDA) held a town hall for industry and other interested parties to discuss the Quality Management System Regulation (QMSR). The FDA discussed how the QMSR addresses risk management, risk-based approach, risk-based decisions, and design and development and addressed frequently asked questions regarding these topics.
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 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.
Town Hall Prerequisite Materials
Please review the following learning modules in advance of attending the town hall:
Risk Management, Risk-Based Approach, and Risk-Based Decisions
Presentation Printable Slides Transcript
Design and Development
Presentation Printable Slides Transcript
Event Materials
The presentation, printable slides, and transcript are available on this webpage and at CDRH Learn under “Postmarket Activities,” sub-section “Quality Management System Regulation.”
If you have questions about this town hall, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.