What is the FDA QMSR?
Medical device companies operating in the United States are scrambling to prepare for a key regulatory update in 2026, and 'what is the FDA QMSR?' is now a burning question for their quality and regulatory teams.
The ISO 13485 vs 21 CFR 820 binary has posed a key quality challenge for American medical device manufacturers for a long time. But now that challenge looks to be a thing of the past.
In 2024, the FDA presented the Final Rule for its upcoming Quality Management System Regulation (QMSR), with the intention of harmonizing the US regulation of FDA 21 CFR 820, or the Quality Management System Regulation (QSR), with the international medical device standard of ISO 13485:2016.
FDA 21 CFR 820, also known as the QSR, is a widely adopted regulation that structures the quality management systems of thousands of American medical device manufacturers.
But it's also over 25 years old.
By using the QMSR to bring in elements of ISO 13485 (the international medical device quality management standard in the 8th year of its current revision), the FDA hopes to freshen up its medical device quality requirements and harmonize them with the more recent cGMP expectations of international authorities.
Here's everything you need to know about the FDA QMSR.
QMSR vs QSR
When it launched in 1997, the QSR borrowed from many aspects of ISO 13485:1996, but it hasn't kept pace with ISO's medical device QMS regulatory requirements since then.
The QMSR, in short, is an updated version of the QSR that aligns FDA medical device regulations with the global standard of ISO 13485.
The FDA has been planning to get back into lockstep with ISO 13485:2016 since 2018, but the complexity of the QMSR project coupled with the impact of COVID-19 has delayed the harmonization drive.
Before the QMSR is goes live in early 2026, FDA investigators and auditors will need to be retrained, the Quality System Inspection Technique (QSIT) refreshed, and a string of agency guidance documents updated.
The synchronization of FDA and ISO requirements with the FDA QMSR can only be a positive for medical device manufacturers both inside and outside the US.
The proposed QMSR will help organizations meet the demands of both bodies, and the global harmonization work already seen with initiatives like the MDSAP can take a step further to full international regulatory alignment.
Not only that, the FDA has acknowledged that ISO 13485 offers a stronger framework for medical device quality management than 21 CFR 820 currently provides.
The link between ISO 13485 and ISO 14971, for instance, provides deeper risk management guidance. And the FDA points to multiple ISO 13485 quality systems principles, which are more robust than their current regulation.
In short, the QMSR will ask US medical device manufacturers to do more than they currently do - making expansion overseas much easier as a result.
ISO 13485 vs. 21 CFR 820
Ahead of the FDA's QMSR plans, you may want to refresh yourself with the current differences in the layout and structure of ISO 13485 vs. 21 CFR 820.
Comparing ISO 13485 vs 21 CFR 820 is the first step to understanding the current differences between the two standards, and - crucially - understanding which of those differences will be eroded and resolved by the QMSR harmonization plan.
QMSR gap analysis
See the differences in the right-hand column of the table above?
It's these areas that make the QMSR transition more complex than a simple ISO 13485 adoption — the QMSR is strongly based on ISO 13485, but includes a series of additional requirements as well.
I ran a webinar with DQS in mid-2025 to dive deep into this ISO 13485 vs. QMSR gap analysis, and give medical device quality teams the insights and knowledge they need for a smooth, stress-free QMSR transition.
You can watch the recording right here!
So while the new regulation builds on ISO 13485, key FDA-specific expectations remain, and they can be demanding for smaller teams.
Changes include:
- Control of Records (820.35)
- Records must meet ISO requirements plus FDA-specific rules on signatures, dates, and complaint handling.
- Complaints must include CAPA links and cover labeling or packaging failures.
- Device Labeling and Packaging (820.45)
- FDA retains stricter hands-on labeling and packaging inspection requirements, including manual checks of label samples before release
- Terminology and scope
- The QMSR broadens coverage to include contract sterilizers, relabelers and foreign initial distributors.
- Documentation and QMS terminology will need updates to reflect the new framework.
- Integrated risk management
- Risk now extends beyond pure product design, embracing ISO 14971's broader definition of risk which encompasses regulatory compliance across your entire QMS.
Addressing these changes early can prevent last-minute disruptions as the deadline approaches.
“The QMSR really streamlines expectations.
If your system already aligns with ISO 13485, most of the framework will feel familiar — the challenge is spotting where FDA keeps its unique requirements, such as labeling and complaint records.”
- Yuan Li, Director of Medical Business, NA Operations, DQS
Small and mid-sized manufacturers often face resource constraints, so I recommend concentrating on three high-impact areas first:
- Run a QMSR gap analysis
- Compare your current QMS to ISO 13485:2016 and the new QMSR requirements
- Focus on document control, complaint records and CAPAs first.
- Update and train
- Refresh procedures, and especially their terminology, to reflect QMSR nomenclature.
- Train staff on updated processes and ensure awareness of risk-based thinking.
- Strengthen record-keeping early
- Ensure records are signed, dated, and centrally maintained to meet 820.35 requirements.
- Ensure centralized complaint handling, with easily navigable links to their associated CAPA records
QMSR compliance as advantage
Working hard and early on the QMSR transition can streamline how your company manages its quality, if you consider that:
- Early gap analysis avoids last-minute document overhauls
- Updated records and training build confidence for FDA inspections
- Structured, centralized complaint and CAPA management saves time across audits and submissions, like 510(k)s or PMAs
The QMSR will demand more from smaller teams, but early preparation can turn a looming compliance project into a manageable, step-by-step plan.
Focus on critical areas first — records, complaints and training.
When your foundation is solid, the QMSR transition becomes far less intimidating.
