> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Town Hall on Quality Management System Regulation
- URL: https://www.fdaweb.com/fda-town-hall-on-quality-management-system-regulation/
- Published: 2026-01-06T12:00:00.000Z
- Updated: 2026-09-14T15:29:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160439

FDA is announcing a [1/14 town hall](https://www.fda.gov/medical-devices/medical-devices-news-and-events/town-hall-quality-management-system-regulation-risk-and-design-and-development-01142026?utm%5Fmedium=email&utm%5Fsource=govdelivery) to discuss its Quality Management System Regulation (QMSR), particularly how it addresses medical device risk management, risk-based approaches, risk-based decisions, and design and development. The Medical Devices Quality System Regulation Amendments [final rule](https://www.federalregister.gov/public-inspection/2024-01709/medical-devices-quality-system-regulation-amendments?ref=fdaweb.com) was published on 2/2024, with an effective date of 2/2/2026.

QMSR harmonizes U.S. medical device GMPs with ISO 13485, adding explicit requirements for risk-management activities. While the agency does not plan new compliance programs or inspection protocols solely because of QMSR, CDRH associate director for compliance and quality **Keisha Thomas** stressed last month ([see story](https://www.fdaweb.com/device-compliance-official-flags-quality-gaps-rising-enforcement/)) that FDA will place far greater emphasis on how firms make risk-based decisions across the total product life cycle.

“When you look at complaint handling, CAPA, and MDR issues — the underlying thread is a risk-management system that isn’t optimal,” she said. “That is going to be the focus under QMSR.” Thomas encouraged firms to ensure they are prepared for risk-management expectations embedded in ISO 13485:2016, now incorporated directly into FDA’s quality-system requirements.

Looking ahead to 2026, Thomas said CDRH will continue to expand its risk-based enforcement approach, using analytics and signal trending across both product categories and corporate structures. CDRH will also intensify scrutiny of unapproved or unlawfully marketed devices, an area she said now accounts for the majority of Warning Letters. In FY 2025, about 61% of device Warning Letters cited unapproved or improperly marketed products, down from about 70% in FY 2024.

CDRH will further focus enforcement on data integrity and data quality in clinical trials and submissions, which Thomas described as a “significant safety issue” when compromised.