Readiness Checklist: Preparing for FDA's 2026 QMSR

As a medical device innovator or manufacturer, what do you need to know and what do you need to do with less than six months to go to the 2026 FDA QMSR Transition? Read on. 

On February 2, 2026, FDA's new Quality Management System Regulation (QMSR) takes effect, replacing the current Quality System Regulation (QSR) and incorporating ISO 13485:2016 by reference. If you're a physician innovator, engineer, or medical device startup, understanding these changes now is crucial for your product development journey. 

Author: Paige Sutton-Smith

Why FDA Made This Change 

The FDA's move to align 21 CFR Part 820 with ISO 13485:2016 represents a significant step toward global regulatory harmonization for medical device innovation. For decades, medical device innovators faced the challenge of navigating different quality system requirements for different markets: FDA's QSR for the United States, ISO 13485 for Europe and most other global markets. This created duplicate effort, increased costs, and delayed patient access to innovative devices. By incorporating the internationally recognized ISO 13485 standard, FDA is trying to make it easier for medical device companies to develop once and deploy globally, while maintaining the rigorous safety and effectiveness standards with which the agency is charged. The FDA QMSR transition and harmonization with ISO 13485 also supports programs like the Medical Device Single Audit Program (MDSAP), where multiple regulatory authorities can rely on shared audit processes. 

Quick Summary 

• Effective Date: February 2, 2026 - FDA will begin enforcing QMSR requirements 

• Key Change: FDA QMSR replaces QSR and substantially incorporates by reference the ISO 13485:2016 international standard 

• Impact: Substantial alignment with international requirements, but additional FDA-specific requirements remain for medical devices authorized for sales in the United States. 

• Action Needed: If you have not done so, start assessment and transition planning now. It may seem like there is still plenty of time to do this, but implementation is complex. 

Your 2026 QMSR Deadline and Transition Checklist 

Assessment Phase (Start Now)

Hopefully you have already done this or are well on your way. If not, you still have time. However, there are important changes in terminology and definitions which will require all-encompassing updates to your QMS if you need or intend to comply with both 21 CFR 820 for FDA and ISO 13485 for EU, MDSAP, and other regions. This is especially important where FDA has specifically superceded ISO definitions. 

If you have devices that support or sustain life, be especially careful how you are implementing Clause 7.5.9.2, as there are additional FDA requirements now beyond the scope of ISO 13485. 

You need to update documents to remove obsolete CFR references and definitions. Consider changing specific references to a general one, for example: "21 CFR 820.181" to "21 CFR Part 820". Make a plan for how you will refer to your existing DHF, DMR, and DHR. These may seem like small changes, but they will prevent future confusion as regulations evolve. 

Strategic Planning Phase 

Decide if the timing of your management review and internal audits are impacted by the harmonization date. Should you hold your management review early (before the transition date) or push it out (after the transition date)? Assess this based on your specific situation. Consider that you will be operating under two different regulatory frameworks during the transition period, which can create confusion and compliance gaps. 

Decide if you want to keep the independent reviewer in your design process. While this can still be a valuable part of your design process, the official requirement will be removed during the transition. If will remove this requirement, consider changing this practice in line with ongoing design project timelines. For example, if you are about to close out a significant design phase which requires an independent reviewer, align the change in coordination with this activity to minimize impact to documentation already in progress.  

Documentation Transition 

If you do not already have a process for controlling documents of external origin, you will need to implement one prior to the transition. Review which standards you have, if they are the correct versions, if you need to purchase new versions, and especially if you need an entirely new process for this. This was not previously an explicit FDA requirement, and as such, companies not already following ISO 13485 have a wide variety of systems in place – or not in place – for this process. This can be a significant gap for companies that have only focused on FDA compliance in the past. 

The device master record (DMR) to medical device file (MDF) transition presents the need for a formalized device description and intended use/purpose statement document. While this generally this should already be part of the design history file (DHF), some devices have different device descriptions or intended use statements for different regions, so there may be a need to create standalone US documents for the US MDF. 

Additionally, some manufacturers have the DMR deeply incorporated into their manufacturing process. This could be complicated to remove if the process is heavily intertwined with the DMR. Manufacturers can choose to maintain this system in order to not disrupt their manufacturing processes; however, they will need to ensure that they completely comply with the MDF requirement separately, and that high-level documentation clearly identifies the contents and location of the MDF. Simply put, you can maintain a standalone DMR process for your internal use if it makes sense for you. This should be considered on a case-by-case basis and is a complex decision on which we are prepared to advise. 

2026 QMSR Transition Document Updates Checklist 

• Update documents with new CFR references and, where applicable, ISO 13485 references 
• Update definitions to be aligned with new/revised definitions 
• Incorporate DMR (Device Master Record) into MDF (Medical Device File) 
• Update scope and structure of Quality Manual 
• Consider re-aligning procedures/processes to follow ISO 13485 structure 
• Align risk management process with ISO 14971 
• Incorporate "analysis of data" process 
• Update CAPA process to align with specific ISO 13485 "Improvement" requirements 
• Include process for control of external documents 

Special 2026 QMSR Transition Considerations 

These requirements have not substantially changed, but FDA has doubled down on their importance by keeping them separate from ISO 13485 and giving this topic its own clause in the FDA QMSR. QMSR places special emphasis on inspection of packaging and labels prior to their use, as well as documenting this inspection. Prepare for the transition with a gap assessment or an audit of your current labeling and packaging procedures. The Veranex team has high levels of proficiency to identify and effectively address related gaps.  

If you are already in compliance with ISO 13485, and your device supports or sustains life, pay special attention to Clause 7.5.9.2 implementation. Devices that support or sustain life are included in the scope of Clause 7.5.9.2 under the QMSR. If you were previously claiming an exclusion to this clause based on yoru lack of implantable medical devices, but you do have life supporting or sustaining devices, you will need to remove this exclusion and comply with the clause.  

Frequently Asked Questions for the Nascent 2026 QMSR Transition

Q: What if I'm a U.S.-only company that has never dealt with ISO 13485?  

A: The 2026 QMSR transition will be particularly challenging for you. You may need to build entirely new processes for certain areas such as those for external document control and analysis of data or potentially overhaul specific areas such as risk management. Start with a comprehensive gap analysis immediately. 

Q: Do I need ISO 13485 certification to comply with new FDA QMSR requirements?  

A: No Manufacturers are not required to obtain certification to ISO 13485, nor will FDA rely on such certification for oversight activities. However, your QMS must comply with ISO 13485:2016 requirements as incorporated by reference. 

Q: Should I start implementing QMSR requirements before February 2026?  

A: Yes! FDA recognizes the importance of manufacturers preparing to align their practices with the QMSR as soon as practical, and some manufacturers may choose to begin complying with the QMSR before the effective date. FDA specifically allowed 2 years for this transition – beginning in February 2024. 

 Q: What if I have ongoing FDA submissions in 2025?  

A: Ongoing FDA submissions may or may not be impacted depending on the type of device and circumstances of the submission. Connect with one of our experts to discuss your specific situation in more detail. 

Q: How will FDA inspections change?  

A: FDA plans to replace its Quality System Inspection Technique (QSIT) with a new inspection program aligned with QMSR. FDA will now inspect Management Review, Quality Audits, and Supplier Audits reports, removing previous exemptions. 

The Bottom Line 

The FDA QMSR transition represents a significant step toward global regulatory harmonization, potentially making international market access easier for innovative medical devices. For physician innovators and device startups, early preparation isn't just recommended; it's essential for maintaining development timelines and market access. 

Start your gap analysis now. The transition may seem straightforward if you're already familiar with ISO 13485, but the implementation details require careful planning. Many of these changes involve complex, case-by-case decisions that depend on your specific manufacturing processes and device types. Your future self, your investors, and your patients will thank you for starting early. 

Remember, this is complex work. Some aspects of this transition may require expert guidance to navigate properly. 

Need personalized guidance on FDA QMSR transition planning? Consult a Veranex quality systems expert who can help assess your specific situation and develop a tailored compliance strategy.