Medtech Implementation of FDA’s Updated QMSRMedtech Implementation of FDA’s Updated QMSR
Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to one expert.
January 13, 2025

Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim Trautman, managing director at Trautman International Services, a Reston, VA-based strategic, quality, and regulatory affairs consulting and training firm for medical devices, in vitro diagnostics, and combination products.
Trautman will be one of three panelists discussing how to navigate the updated regulation at next month’s MD&M West show in Anaheim, CA. She shared some of her expertise with MD+DI.
Why a panel discussion on QMSR as opposed to a solo speaker?
Trautman: Earlier that day, I will present the QMSR topic technically. The panel is meant to bring in a variety of inputs.
One of the major changes with the regulation is the incorporation of the ISO 13485:2016 standard, which is required by other international regulatory agencies. Thus, many companies have already been complying with the ISO standard to market in international geographies. Numerous companies will find that this updated FDA regulation is much ado about nothing, except for how FDA may inspect the requirements differently from other international regulatory auditors.
But those companies that solely sell in the United States might have some challenges needing action during the two-year transition period. The panel will discuss issues for companies that are limited to domestic sales, as well as companies that do global sales and distribution.
What are major elements of the updated FDA QMSR?
Trautman: The biggest change is that FDA has incorporated the ISO 13485:2016 standard, in its entirety, into the U.S. regulation to include the normative reference ISO 9000:2015 terms and definitions.
In certain sections of the QMSR, FDA has also laid out cases where the agency will maintain the 1996 Quality System (QS) regulation requirements. Those requirements that are maintained have not been revised. A lot of the newly structured QMSR is related to FDA’s linkages of the quality system requirements to other FDA regulations like adverse event reporting, tracking, unique device identification, corrections, and removals.
Any barriers for manufacturers to achieve the February 2026 compliance deadline, and how to overcome them?
Trautman: For companies just doing sales in the United States, there will be some additional increases in expectations, including the life cycle requirements of risk management, which are now going to be much more explicit in the ISO 13485:2016 standard compared to the 1996 QS regulation.
The ISO 13485:2016 standard, having been revised in 2016, has evolved with quality and risk science. There is an explicit life cycle approach and requirements for risk management more than the 1996 regulation. So, there are increases in expectations and increases in certain details that manufacturers that have traditionally sold only in the United States will have to address.
Fortunately, industry has been on notice with the draft regulation since 2022.
Any challenges for quality leaders?
Trautman: Understanding and keeping up with FDA’s new inspection model that will be coming out for the QMSR in 2025. Also, comprehending some of the increased expectations with certain other topics like supplier controls and competency vs. training.
When the updated Device Guide to Inspections is published by FDA, quality managers will absolutely need to stay on top of those changes.
Any obstacles for regulatory professionals?
Trautman: Hopefully, their lives will actually become easier because the update will provide fewer differences between different regulatory geographies. And with this harmonization, there should be no new obstacles.
Do you anticipate additional FDA QMSR regulations?
Trautman: I don’t foresee any new or additional revisions for awhile. However, FDA will need to stay current with any revision to the ISO 13485:2016 standard.
As ISO 13485:2016 revises, which is required by ISO rules, FDA will need to review those new revisions and determine what action to take, if any.
The FDA QMSR is a very good harmonization effort and a positive step. The barriers and obstacles should be minimal at best. Any perceived challenges to implementation are probably due to misunderstanding the intent of any requirements.
About the Author
You May Also Like