What Small Businesses Need to Know About ISO 13485 and the New FDA Rule for Medical Devices
If you own a small business that makes or sells medical devices in the U.S., there is an important change in regulations. You should be aware of this change.
The FDA is updating its quality system rules. This change will align with ISO 13485. ISO 13485 is a well-known standard for managing the quality of medical devices.
What’s Changing?
The FDA has released a final rule. This rule replaces much of the current Quality System Regulation (QSR) in FDA Rule 21 CFR Part 820 with ISO 13485:2016. This change is all about harmonizing U.S. regulations with international standards to streamline global compliance.
👉 Effective Date: February 2, 2026
Until then, manufacturers must continue to follow the current QSR—but now is the time to prepare for the switch. The new management system that incorporates ISO 13485:2016 will call itself the quality management system regulation (QMSR).
What is ISO 13485?
ISO 13485 is a quality management system standard designed specifically for medical device manufacturers. It ensures that devices are safe and effective and meet customer and regulatory requirements.
In what way does the new FDA rule relate to ISO 13485?
The rule changes the title of the regulation. It also adds new requirements that explain some expectations and concepts in ISO 13485. These changes make sure that using ISO 13485 does not cause any conflicts with other FDA rules.
We refer to this revised part 820 as the Quality Management System Regulation (QMSR). The FDA has made changes to part 4 (21 CFR part 4). These changes clarify the rules for the Quality Management System (QMS) related to combination products. These edits do not impact the good manufacturing practices or CGMP requirements for combination products.
Key Benefits of ISO 13485 Compliance
Effective Risk Management
ISO 13485 provides tools for good risk management. It helps create consistency in your organization to ensure safe and reliable products.
QMS Practices for Safe and Effective Medical Devices
ISO 13485’s Quality Management System (QMS) practices establish protocols for quality control, ensuring safe and effective products. With compliant oversight, monitoring, and accountability, you can consistently meet critical requirements for medical device production.
Foundation for Compliance With FDA, EU’s Medical Devices Regulation 2017/745 (MDR), or CE
ISO 13485 compliance is often the first step for manufacturers. They seek to comply with the Medical Devices Regulation (MDR) and the CE marking process in the European Union.
Many countries now base their regulatory requirements on ISO 9001 and 13485. For example, the U.S. revised Quality System Regulation (FDA 21 CFR 820) incorporates both standards.
ISO 13485 references the ISO 9001:2008 standard, not the latest 2015 version. However, ISO 13485 goes beyond ISO 9001 with many controls specific to medical devices.
Improved Processes and Efficiency
ISO 13485 requirements help you streamline their regular processes. With the monitoring and evaluation required by ISO 13485, you can establish efficient systems and optimize productivity across your organization. Standardizes processes to cut waste and increase productivity.
New Business Opportunities
Because ISO 13485 requirements are recognized worldwide, certification exposes you to a broader market. When you show that you follow a well-known standard, you can attract new customers. It also helps manage risks by finding and reducing them in product development and manufacturing.
ISO 13485:2016 compliance helps with global market access. It makes it easier to sell in other countries by meeting international standards. It also boosts reputation – demonstrates to clients, collaborators, and authorities that you value quality and safety.
What You Need to Do
Between now and 2026, your business should:
- Review and revise internal quality procedures and training materials
- Update agreements and documentation that reference the old QSR
- Implement an ISO 13485 2016 Quality Management System for Medical Devices
- Get ready for changes in FDA inspections. They will now need more records, like audit reports, for review.
- Make sure your quality system includes design and development controls, complaint handling, UDI compliance, and other updated requirements
ISO 13485 and the old QSR are similar in many ways. However, their structure and language are different. So, don’t expect a perfect match.
Frequently Asked Questions
Q: Why is the FDA doing this?
A: The goal is to align U.S. rules with global standards. This will help companies compete internationally.
Q: Will FDA inspections change?
A: Yes. A new inspection process will roll out to match the new Quality Management System Regulation (QMSR). Expect to see changes by 2026.
Q: What will happen if someone updates ISO 13485 in the future?
A: If ISO updates the standard, the FDA will review the changes and decide whether to amend its rule.
Summary
- The new rule takes effect February 2, 2026
- It replaces most of the FDA’s QSR with ISO 13485:2016
- You don’t need ISO certification, but your system must comply with the standard
- Start preparing now to avoid disruption in 2026
Need help getting ready?
At Core Business Solutions, we help small businesses set up and maintain compliant quality management systems, including ISO 13485. Whether you need consulting, auditing, or a simple platform to keep things on track—we’re here to support you.
Contact us today to learn more or get a free quote.
About Scott Dawson
From 2010-2025, Scott Dawson, President of Core Business Solutions, was an active voting member of the U.S. Technical Advisory Group (TAG) to ISO Technical Committee 176 (TC 176). TAG 176 members meet to discuss and develop U.S. positions for Quality Management standards, including ISO 9001:2015, which will be revised in 2026. Our Director of Consulting Services now stays involved in the U.S. TAG 176.
